Protocol
Abstract
Background: Care partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes.
Objective: The primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention that incorporates passive mobile sensor data feedback (sleep and activity data from a Fitbit [Fitbit LLC]) and real time self-reporting of HRQOL via a study-specific app called CareQOL (University of Michigan) to provide personalized feedback via app alerts.
Methods: Participants from 3 diverse care partner groups will be enrolled (care partners of persons with spinal cord injury, care partners of persons with Huntington disease, and care partners of persons with hematopoietic cell transplantation). Participants will be randomized to either a control group, where they will wear the Fitbit and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the just-in-time adaptive intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. At the end of the study, participants will complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated.
Results: This trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in 2022.
Conclusions: This trial will determine the feasibility and acceptability of an intensive app-based intervention in 3 distinct care partner groups: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury); care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease); and care partners for persons with episodic cancer conditions that require intense, prolonged inpatient and outpatient treatment (persons with hematopoietic cell transplantation).
Trial Registration: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591
International Registered Report Identifier (IRRID): DERR1-10.2196/32842
doi:10.2196/32842
Keywords
Introduction
Background
Care partners (ie, informal family caregivers) of individuals with health problems are faced with considerable physical and emotional stress [
- ], often with a substantial negative impact on the health-related quality of life (HRQOL) of both the care partner [ - , , , - ] and care recipient [ , - ]. Care partners may suddenly be thrust into this full-time role and are often unprepared. As responsibilities accumulate, they face emergent health risks, including anxiety, fatigue, isolation, sleep problems, and decreased physical activity. Indeed, there is growing recognition that these psychological, social, and physical risks inadvertently affect patient health and well-being (ie, outcomes) [ , , , - , - ]. Thus, it is imperative to develop novel interventions to support care partners to ensure better patient outcomes.Despite the growing awareness regarding the importance of caregiving with the aging US population and evolving health care system, very little action has been taken to understand and improve conditions for care partners [
, , ]. Thus, family caregiving (ie, care partners) is an urgent public health issue. With a high risk for developing depression, insomnia, and stress-related disorders [ , - , - ], care partners are an ideal population to target for early detection and intervention strategies to treat compromised well-being. Although psychoeducation, skills training, or therapeutic counseling interventions can be effective for care partners, these interventions require intensive time and face-to-face commitment (with trained personnel), which can be prohibitive for an individual who is already overwhelmed by existing caregiving responsibilities and unable to make time for self-care.Objectives
This pilot study is designed to examine the acceptability and feasibility of an intensive data collection protocol that involves the delivery of a personalized self-management intervention to promote care partner self-care. Care partners from 3 distinct groups will be examined: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury [SCI]), care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease [HD]), and care partners for persons with an episodic cancer condition that requires intense, prolonged inpatient and outpatient treatment (persons with allogeneic hematopoietic cell transplantation [HCT]). Care partners will be randomized to either the control group, where they will wear the Fitbit (Fitbit LLC) and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. The intervention is a just-in-time adaptive intervention (JITAI), that is, an emerging intervention that uses real time data collection to inform and personalize the delivery of the intervention [
, ]. Studies in other populations, including cardiovascular disease, diabetes, mental illness, and smoking cessation, support JITAI’s efficacy in improving physical, mental, and social health outcomes [ - ]. We describe the design and protocol of this trial in the following sections.Methods
Participants and Setting
Overview
Data collection will include a diverse sample of N=60-90 care partners (n=20-30 SCI, n=20-30 HD, and n=20-30 HCT care partners). A care partner is defined as a person who provides physical assistance, financial assistance, or emotional support and who is not a professional, paid caregiver. Participant recruitment and enrollment will take place at the University of Michigan. The study was designed to be fully remote, given the ongoing restrictions related to the COVID-19 pandemic.
Inclusion Criteria
Care partners must be (1) aged at least 18 years, (2) able to read and understand English, and (3) caring for an adult (aged ≥18 years) with medically documented HD, SCI, or HCT. Care partners must be providing some form of care to the person with HD, SCI, HCT. Specifically, care partners must indicate a response ≥1 on the following question:
On a scale of 0-10, where 0 is ‘no assistance’ and 10 is ‘assistance with all activities,’ how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her HD/SCI/HCT? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc.
Care partners must also have access to necessary resources for participating in a technology-based intervention (smartphone or tablet and internet access) and be willing to use their personal equipment or internet for this study, including downloading the CareQOL app (University of Michigan) and the Fitbit app on their mobile device, and be willing to complete all study assessments for the duration of study participation. Care partners of persons with SCI must be caring for an individual who is ≥1 year post injury and has a medically documented injury. Care partners of persons with HCT must indicate that they are caring for an individual who is receiving, has received, or is scheduled to receive HCT.
Exclusion Criteria
Professional, paid care partners (eg, home health aide) will be excluded from this study.
Recruitment and Screening
Care partners will be recruited through existing clinical databases [
], registries, and relevant patient clinics at the University of Michigan, as well as through a study posting on UMHealthResearch.org and outreach to relevant community groups and organizations. Care partners will be recruited directly or through the person for whom they provide care. Individuals interested in participating will be encouraged to ask questions about the study and their participation, and if they opt to enroll, they will provide informed consent before completing any study assessments.Study Design
This pilot trial will use a 2-arm, randomized controlled design. Each of the 60 to 90 care partner participants will be randomized to an active JITAI arm (n=10-15 care partners of patients with SCI, n=10-15 care partners of patients with HD, and n=10-15 care partners of patients with HCT) or to a control arm (n=10-15 care partners of patients with SCI, n=10-15 care partners of patients with HD, and n=10-15 care partners of patients with HCT). The random allocation of participants to the treatment or control arm establishes the basis for testing the statistical significance or difference between the groups. All participants (regardless of study arm) will complete a baseline assessment comprising several self-report surveys designed to evaluate sample characteristics (ie, demographic information, medical history data, and patient characteristics) and HRQOL (CareQOL measures, as well as other caregiving measures and measures about the functional capabilities of the person with HD, HCT, or SCI). This is followed by a 10-day run-in period to allow for the shipping time of the Fitbit and to provide the participants time to familiarize themselves with the study technology (Fitbit and CareQOL app) and procedures. This period will also allow the study team to troubleshoot any potential barriers or issues that arise before the official start of the home monitoring period. For those who are randomized to the JITAI group, it will also allow for data collection that can be used to inform the intervention messages once the home monitoring period begins. This will be followed by a 3-month (90 days) home monitoring period during which participants will wear a wrist-worn Fitbit (to continuously monitor physical activity and sleep), as well as complete daily real time ratings of HRQOL (ie, single-item assessments of caregiver strain, anxiety, and depression). Those randomized to the JITAI group will have a 50/50 chance of receiving notifications each day during the home monitoring period (intervention details provided below). At the end of months 1 and 2, all participants will also complete a longer battery of self-report surveys on HRQOL (also delivered via CareQOL app), and at the end of 3 months, participants will complete this longer survey battery plus a feasibility and acceptability questionnaire (again delivered via the app).
Study Procedures
Overview
Unless they opt to use their own personal Fitbit, participants will receive a Fitbit for the collection of sleep and activity (steps) data and will download the Fitbit app and study app, CareQOL, on their personal mobile devices (iOS or Android). The CareQOL app will deliver ecological momentary assessments (EMAs) once per day, compile and display data (including those collected on the Fitbit), deliver study notifications, including messages for the participant to complete the daily EMA and other study surveys, and deliver the personalized study intervention prompts to the intervention group (JITAI group).
All study participants will complete 3 EMA questions daily on the CareQOL app. Each participant will be prompted by a push notification in a 5-hour window (based on participant preference) from the app to answer the questions. The EMA questions comprised 1 question on care partner strain (taken from the CareQOL Caregiver Strain item bank), 1 question on anxiety (taken from the Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety item bank), and 1 question on depression (taken from the PROMIS Depression item bank). These questions will be administered as a computer adaptive test such that each day’s item will be based on the previous day’s response. Questions are on a 5-point scale, with higher scores indicating more of the named construct.
In addition to the collection of EMA data, the app compiles and displays a graphical summary of historical data for care partner stress (strain), worry (anxiety), sadness (depression), steps (collected by the Fitbit), and hours of sleep (collected by the Fitbit) on a participant dashboard. Participants can view this information for the past week, month, or year (
). This is available to all participants as a pull—that is, it is available at all times but is accessed only if and when the user chooses to access it.Care partners will be provided compensation for their participation in this study. Incentives will be identical for both groups (JITAI and control): US $20 compensation for the completion of the baseline assessment, US $10 for completion of each of the end-of-month assessments, US $1 per day for each day that they have EMA or Fitbit data during the home monitoring period, and the option to keep the Fitbit at the end of the study.
Randomization
Blocked randomization will be used to limit bias and achieve an equal distribution of participants to the control and treatment arms. A randomization list will be generated for each condition (SCI, HD, and HCT), and the study statistician will oversee randomization. The participants will be randomized once they are deemed eligible, have provided informed consent, and have completed the baseline assessments. The study coordinator or research assistant who consented the participants will use the appropriate condition’s randomization list to assign the participant to the correct study arm. Half of the participants will be randomized to receive the intervention (JITAI; described below); the remaining participants will be in the control group, who will not receive the JITAI but will complete the activities already described in this section. Participants who are randomized to receive the JITAI will have a 50/50 chance of receiving the intervention each day.
Intervention
The JITAI aims to promote behavioral change through motivational messages delivered through the CareQOL app as push notifications. These notifications provide a trigger for participants to initiate or continue behavior change or monitor behaviors (through engagement with the app); they are broadly based on the behavioral activation theory, which posits that negative life events (eg, difficult interactions between the care partner and care recipient and increased care partner stress because of caregiver role overload) trigger negative emotional responses (eg, depression and anxiety) that lead to unhealthy behavioral patterns (eg, poor sleep, decreased exercise, and social withdrawal), which starts the cycle all over again [
]. Specifically, the notifications are designed to foster care partner self-management by targeting behavioral change (ie, through increased physical activity and better sleep habits) and by promoting positive mental health responses (eg, self-efficacy, positive affect, and well-being). Behavioral activation (including behavioral activation delivered via SMS text messaging) is effective for treating both anxiety and depression as pure constructs and also for persons who are experiencing a mixture of the two [ - ].The push notifications are low burden: participants can personalize the administration time (in a 5-hour window), and notifications can be viewed quickly on their phone’s lock screen. Participants can also choose not to engage with the notification at the time it is sent if it is inconvenient—they can return to it later if needed.
The JITAI push notifications are aimed at promoting healthy behaviors (physical activity and good sleep hygiene) and improving mood (anxiety, depression, and care partner strain). If a notification is to be sent, the content will be randomly drawn from this pool of messages. Some messages will use participants’ data directly in the messages (eg, you walked an average of 8120 steps this week), and most of the messages will be personalized based on data (eg, someone with low steps will get a different message than someone with medium steps than someone with high steps; high-medium-low). Messages comprise one or more of the following types: (1) data feedback, (2) facts, (3) tips, and (4) support.
provides specific examples of personalized push notifications that will be used in this study.Randomization of the days the participants receive messages and the messages the participants receive from the pool will be done through the CareQOL app.
Feedback domain | Intervention options | ||
Low level (below average performance or problems) | Medium level (average performance or problems) | High level (above average performance or problems) | |
Mental health (depression) | “Your average sadness rating over the last week was XX. Next time you’re feeling low, watch your favorite funny movie. Laughter is the best medicine!” | “Your average sadness rating over the last week was XX. When you’re feeling low, why not watch your favorite funny movie? Laughter is the best medicine!” | “Your average sadness rating over the last week was XX. If you’re ever feeling low, watch your favorite funny movie. Laughter is the best medicine!” |
Mental health (anxiety) | “The next time you feel worried, close your eyes and think of a peaceful, relaxing place. Try to imagine as many different sights, sounds, and smells as you can. Continue until you feel more relaxed, then open your eyes slowly.” | “Are you feeling anxious? Close your eyes and think of a peaceful, relaxing place. Try to imagine as many different sights, sounds, and smells as you can. Continue until you feel more relaxed, then open your eyes slowly.” | “If you ever feel worried, close your eyes and think of a peaceful, relaxing place. Try to imagine as many different sights, sounds, and smells as you can. Continue until you feel more relaxed, then open your eyes slowly.” |
Mental health (general) | “Is there a friend you haven’t talked to in a while? When you feel down, try giving them a call. Talking to friends can help boost your spirits!” | “Is there a friend you haven’t talked to in a while? Try giving them a call. Talking to friends can help boost your spirits!” | “Is there a friend you haven’t talked to in a while? If you feel down, try giving them a call. Talking to friends can boost your spirits!” |
Mindfulness | “Take a few minutes every day to wind down. Even if you don’t feel stressed all the time, meditating can relieve built up tension.” | “Take a few minutes every day to wind down. Try meditating to relieve built up tension.” | “Take a few minutes every day to wind down. Even if you don’t feel stressed right now, meditating can relieve any built-up tension.” |
Physical activity | “This past week, your average daily step count has been XX. Try to increase this if you can!” | “This past week, your average daily step count has been XX. Try to maintain this level, or even increase it more if you can.” | “This past week, your average daily step count has been XX. Great job! Try to maintain this level.” |
Sleep | “You aren’t quite getting the recommended 7-8 hours of sleep per night. Try moving bedtime up by 5-10 minutes each night to get closer to this goal.” | “You’re having a hard time getting the recommended 7-8 hours of sleep per night. We all struggle to get to sleep sometimes. Try moving bedtime up by 5-10 minutes each night.” | “If you ever having a hard time getting the recommended 7-8 hours of sleep per night, try moving bedtime up by 5-10 minutes each night.” |
Outcomes
The primary objective of this study is to establish the feasibility and acceptability of our intensive data collection protocol.
provides a detailed summary of the study assessments, and provides the schedule of activities.The primary end point will examine survey responses on the feasibility and acceptability questionnaire designed to evaluate our intensive data collection protocol in the full sample. Secondary end points will include attrition and adherence estimates (again across the full sample). Exploratory analyses will be conducted to identify trends for an improvement in HRQOL scores (ie, group differences between the JITAI and control groups at the end of the 3-month home monitoring period, with the hypothesis that the JITAI group will report better outcomes than the control group). Exploratory analyses may also compare important subgroups (eg, care partner groups that differ by diagnosis [SCI, HD or HCT], relationship type [parent vs spousal care partners], sex [male vs female care partners], and according to the functional status of the person they are caring for). Exploratory analyses will use an intention-to-treat approach where the participant will contribute data to the arm they are randomized to, regardless of the amount of data contributed (ie, the duration of participation).
Outcome measure and description of outcome measure | Assessment schedule | ||||||||
Baseline | Dailya | 1 and 2 months (30 and 60 days) | 3 months (90 days) | ||||||
Demographic information | |||||||||
Study-designed form used to capture demographic data, including age, gender, race, ethnicity, education, marital status, work status, COVID-19 history or status, care partner data, care recipient data, and caregiving demands | ✓b | ||||||||
Care recipient medical record information | |||||||||
Study-designed form with information about the person with SCIc, Huntington disease, or HCTd for whom the care partner is providing care (eg, date of diagnosis, details of diagnosis, and disease stage or severity) | ✓ | ||||||||
Caregiver Appraisal Scale [ | ]|||||||||
47 items that assess positive and negative aspects of the caregiving role; 4 separate subdomain scores (perceived burden, caregiver relationship satisfaction, caregiving ideology, and caregiving mastery) can be calculated; higher scores indicate better functioning; reliability and validity supported [ | ]✓ | ||||||||
Self-report version of the United Huntington Disease Rating Scale Independence Scale [ | ]|||||||||
Care partner–reported rating provides an estimate of the current level of the independence for the person that they care for; this measure is rated from 1 to 100 in intervals of 5, with higher ratings indicating higher level of independence; reliability and validity supported [ | ]✓ | ||||||||
Supervision Rating Scale [ | ]|||||||||
Single rating that the care partner provides about the overall amount of supervision that the person they care for receives; ratings range from 1 to 13, with higher ratings indicating greater levels of required supervision; reliability and validity supported [ | ]✓ | ||||||||
TBI-CareQOLe Caregiver Strain SFf [90,91] | |||||||||
Assesses perceived feelings of feeling overwhelmed, stressed, and beat-down related to the care partner role; scored on a t metric (mean 50, SD 10), with higher scores indicating more strain; reliability and validity supported [ | - ]✓ | ✓ | ✓ | ||||||
TBI-CareQOL Caregiver-Specific Anxiety SF [ | , ]|||||||||
Assesses care partner perceived feelings of worry and anxiety specific to the safety, health, and future well-being of the person with TBIg; scored on a t metric (mean 50, SD 10), with higher scores indicating more anxiety; reliability and validity supported [ | , , ]✓ | ✓ | ✓ | ||||||
PROMISh Sleep-Related Impairment SF [ | ]|||||||||
Evaluates the effect of poor sleep on daytime functioning; scored on a t metric (mean 50, SD 10), with higher scores indicating more sleep-related impairment; reliability and validity supported [ | , - ]✓ | ✓ | ✓ | ||||||
PROMIS Fatigue SF [ | , ]|||||||||
Evaluates self-reported symptoms of fatigue, ranging from mild subjective feelings of tiredness to overwhelming exhaustion that may decrease one’s ability to perform activities of daily living; scored on a t metric (mean 50, SD 10), with higher scores indicating more fatigue; reliability and validity supported [ | , - , - ]✓ | ✓ | ✓ | ||||||
PROMIS Anxiety SF [ | , ]|||||||||
Assesses self-reported feelings of fear, anxiety, and hyperarousal; scored on a t metric (mean 50, SD 10), with higher scores indicating more anxiety; reliability, validity, and responsiveness supported [ | , - , , ]✓ | ✓ | ✓ | ||||||
PROMIS Depression SF [ | , ]|||||||||
Assesses self-reported feelings of sadness and worthlessness; scored on a t metric (mean 50, SD 10), with higher scores indicating more depression; reliability, validity, and responsiveness supported [ | , - , , , ]✓ | ✓ | ✓ | ||||||
PROMIS Anger SF [ | , ]|||||||||
Assesses self-reported feelings of irritability and frustration; scored on a t metric (mean 50, SD 10), with higher scores indicating more anger; reliability, validity, and responsiveness supported [ | , , , ]✓ | ✓ | ✓ | ||||||
NIHi Toolbox Self-Efficacy–General SF [ | ]|||||||||
Assesses self-reported confidence in the ability to successfully perform specific tasks or behaviors related to one’s overall functioning; scored on a t metric (mean 50, SD 10), with higher scores indicating more self-efficacy; reliability, validity, and responsiveness supported [ | - ]✓ | ✓ | ✓ | ||||||
Neuro-QoLj Positive Affect and Well-Being SF [ | ]|||||||||
Assesses parts of an individual’s life that are related to overall life meaning and purpose, well-being, and satisfaction; scored on a t metric (mean 50, SD 10), with higher scores indicating greater satisfaction; reliability, validity, and responsiveness supported [ | ]✓ | ✓ | ✓ | ||||||
NIH Toolbox Perceived Stress [ | ]|||||||||
Assesses an individual’s feelings about the nature of events and individual coping resources; scored on a t metric (mean 50, SD 10), with higher scores indicating more perceived stress; reliability, validity, and responsiveness supported [ | ]✓ | ✓ | ✓ | ||||||
PROMIS Ability to Participate in Social Roles and Activities SF [ | , ]|||||||||
Assesses involvement in one’s ability to participate in usual social roles and activities; scored on a t metric (mean 50, SD 10), with higher scores indicating more ability to participate; reliability, validity, and responsiveness supported [ | , , , , ]✓ | ✓ | ✓ | ||||||
PROMIS Global Health v1.2 | |||||||||
10 items that assess overall physical, mental, and social health; scored on a t metric (mean 50, SD 10), with separate scores for physical and mental health (higher scores indicate better health); responsiveness and validity supported [ | - ]✓ | ✓ | ✓ | ||||||
COVID HRQOLk | |||||||||
Single item that assesses how concerned the participant is about COVID-19; scores range from 0 to 10, with higher scores indicating greater COVID-19–specific concerns | ✓ | ✓ | ✓ | ||||||
Single-item Caregiver Strain [ | , ]|||||||||
Assesses perceived feelings of feeling overwhelmed, stressed, and beat-down related to the care partner role; scored on a t metric (mean 50, SD 10), with higher scores indicating more strain; reliability and validity supported [ | - ]✓ | ||||||||
Single-item Anxiety [ | , ]|||||||||
Assesses self-reported feelings of fear, anxiety, and hyperarousal; scored on a t metric (mean 50, SD 10), with higher scores indicating more anxiety; reliability, validity, and responsiveness supported [ | , - , , ]✓ | ||||||||
Single-item Depression [ | , ]|||||||||
Assesses self-reported feelings of sadness and worthlessness; scored on a t metric (mean 50, SD 10), with higher scores indicating more depression; reliability, validity, and responsiveness supported [ | , - , , , ]✓ | ||||||||
Fitbit-based estimate of physical activity | |||||||||
Fitbit off-the-shelf summary physical activity data includes steps, sedentary behavior, and light, moderate, and intense activity | ✓ | ||||||||
Fitbit-based estimate of sleep | |||||||||
Fitbit off-the-shelf summary data for total sleep time and time spent in each stage of sleep (awake, rapid eye movement, and light sleep) | ✓ | ||||||||
Medical history, medications, treatments, and COVID questionnaire | |||||||||
Study-specific forms will be used to capture medical history and current treatments or management strategies (medication and nonmedication—eg, exercise and mindfulness) and COVID-19 history | ✓ | ✓ | |||||||
Adverse event or status update | |||||||||
Self-reported changes in mental or physical health | ✓ | ||||||||
Feasibility and acceptability questionnaire | |||||||||
Assesses the experience of the participant with the study methodology and technology, including the CareQOL app, Fitbit, and the JITAIl. Items are scaled from 1 to 5 to indicate level of agreement, where 1 indicates strong disagreement and 5 indicates strong agreement | ✓ | ||||||||
Optional: semistructured interview (JITAI group only) | |||||||||
Assesses participant experiences and perceptions of the intervention messages that they received from the CareQOL app | ✓ |
aDaily surveys will be administered through the run-in and 3-month home monitoring periods.
bAssessment performed.
cSCI: spinal cord injury.
dHCT: hematopoietic cell transplantation.
eTBI-CareQOL: Traumatic Brain Injury Caregiver Quality of Life measurement system.
fSF: short from.
gTBI: traumatic brain injury.
hPROMIS: Patient-Reported Outcomes Measurement Information System.
iNIH: National Institute of Health.
jNeuro-QoL: Quality of Life in Neurological Disorders.
kHRQOL: health-related quality of life.
lJITAI: just-in-time adaptive intervention.
Assessments | Pre-enrollment | Enrollment, day 10 | Approximately 3 monthsa | |||
Run-inb, days –10 to –1 | End of months 1 and 2 | End of 3-month assessment, 90 (±7) days | ||||
30 days | 60 (±7) days | |||||
SCIc, Huntington disease, HCTd documentation | ✓e | |||||
Care partner eligibility | ✓ | ✓ | ||||
Informed consent | ✓ | |||||
Demographics and baseline survey | ✓ | |||||
Caregiver Appraisal Scale | ✓ | ✓ | ||||
UHDRSf Independence Scale | ✓ | |||||
SRSg | ✓ | |||||
Medical record confirmation CRFh | ✓ | |||||
HRQOLi measures | ✓ | ✓ | ✓ | ✓ | ||
Fitbit and CareQOL app instructions | ✓ | |||||
Randomization | ✓ | |||||
JITAIj,k,l and control home monitoring | ✓ | ✓ | ✓ | ✓ | ||
Daily EMAm,n | ||||||
Feasibility and acceptability questionnaire | ✓ | |||||
Medications, therapies, medical history, and COVID-19 | ✓ | ✓ | ||||
Adverse events reporting | ✓ | |||||
Optional: semistructured interviewo | ✓ |
aIndividual participant duration may vary depending on when the participant completes health-related quality of life assessments.
bApproximately 10 days in duration, to include time for shipping and at least 3-4 days of data collection.
cSCI: spinal cord injury.
dHCT: hematopoietic cell transplantation.
eAssessment completed.
fUHDRS: United Huntington Disease Rating Scale.
gSRS: Supervision Rating Scale.
hCRF: Case Report Form.
iHRQOL: health-related quality of life.
jJITAI: just-in-time adaptive intervention.
kActive intervention, including personalized push notifications.
lIncludes daily wearing the Fitbit for sleep and physical activity monitoring.
mEMA: ecological momentary assessment.
nFor both active and control groups.
oOptional semistructured interview for the intervention group only; separate consent required.
Data Collection, Storage, and Protection
This project uses multiple electronic data capture and management platforms, such as Research Electronic Data Capture (REDCap; Vanderbilt University), CareQOL, Qualtrics (Qualtrics), Fitbit, University of Michigan Health Information Technology and Services server, Google Cloud, and Amazon Web Services Cloud. All platforms are designed for human subject research and comply with federal and local data and information security practices. The study data entry and study management systems are secured and password-protected. At the end of the study, all study databases will be deidentified and archived securely at the University of Michigan.
Sample Size Considerations
The main purpose of the current trial is to establish the feasibility and acceptability of an intensive data collection protocol to inform a larger, later-stage effectiveness study on the JITAI in care partners of persons with chronic medical conditions. Thus, this study is designed to provide a point estimate of the effect of the JITAI for the future large-scale trial. Given that there are no formal power analysis calculations for this type of analysis, we have based the proposed sample size on our previous experience conducting these types of trials. Specifically, we believe that approximately 50 participants will provide sufficient numbers and diagnostic diversity to evaluate the feasibility and acceptability of new mobile health apps. Thus, our proposed sample size of N=60-90 care partners (at least 30 per arm and 20 per care partner group) exceeds this estimate and should provide a reasonable range of scores on the HRQOL outcome measures to guide later phase trial work.
Statistics
Sample Descriptive Data
Care partners in each study group (JITAI and control) will be compared descriptively according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines [
]. We will use 2-tailed t tests and/or analysis of variance to examine group differences for continuous variables (eg, age and HRQOL outcomes). Chi-square or Fisher exact tests will be used to examine group differences for categorical variables (eg, care partner type [SCI, HD, and HCT], sex, ethnicity, race, education, marital status, and relationship to care recipient).Primary End Point
We will generate frequency counts for each of the feasibility and acceptability questionnaire items (note: items are scaled from 1 to 5 to indicate the level of agreement, where 1 indicates strong disagreement and 5 indicates strong agreement). Descriptive statistics will also be calculated. We hypothesize that this intensive data collection protocol will be both feasible and acceptable for care partners (regardless of group assignment). Feasibility and acceptability will be measured by ≥80% of participants indicating that care partners either agree or strongly agree that the different study elements are feasible and acceptable.
Secondary End Points
Attrition will be reported as the fraction of participants who will complete the final assessment out of the total number of study participants who completed the baseline assessment. In addition, the completion rates for the EMA assessments, the Fitbit data (ie, steps and sleep), and the monthly surveys will be calculated. Descriptive statistics will be calculated for the missing data across the study. We hypothesize that this intensive data collection protocol will be both feasible and acceptable for care partners (regardless of group assignment). Specifically, we expect ≥80% of participants to complete the study, that ≤60% of participants will be missing data for the daily assessment questions, and ≥80% of participants will complete each of the end-of-month surveys.
Exploratory End Points
We will also conduct analyses to determine if care partners in the JITAI group have better HRQOL at 3 months relative to the control group after controlling for baseline scores. Specifically, we will conduct a series of analyses of covariance to determine if individuals in the JITAI group have significantly better (1) care partner strain (as measured by CareQOL Caregiver Strain), (2) depression (as measured by PROMIS Depression), or (3) anxiety (as measured by PROMIS Anxiety) at 3 months after controlling for baseline scores on each respective measure (eg, analyses looking at 3-month care partner strain scores will control for baseline estimates of care partner strain). In addition, for those participants who will complete the semistructured interviews, we will assess care partners’ perceptions and preferences related to the intervention prompts to allow for future adaptations that involve targeting, tailoring, and personalization of these prompts.
Ethics and Dissemination
All study procedures will be conducted in accordance with the US Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR part 46, 21 CFR part 50, 21 CFR part 56, 21 CFR part 312, or 21 CFR part 812) and research best practices. The study procedures have been approved by Institutional Review Boards of the University of Michigan Medical School (application approval HUM00184455 and registered with ClinicalTrials.gov [NCT04556591]). The study results will be reported according to the CONSORT 2010 guidelines and the 2013 CONSORT Patient-Reported Outcomes extension guidelines [
, ].Results
This study was funded in March 2020 and received institutional review board approval in August 2020. Participant recruitment for this trial began in November 2020 and was completed in June 2021. Dissemination of trial results is forthcoming. We expect to publish the results for the primary outcomes in 2022.
Discussion
Overview
The proposed study aims to investigate the feasibility and acceptability of an intensive data collection protocol that involves the administration of the JITAI intervention to care partners of persons with significant health conditions. This protocol provides a description of the design and methods of this randomized clinical trial.
Although interventions exist to help improve care partners’ HRQOL, they are typically time-intensive and expensive and have limited success in improving HRQOL in these individuals. Despite clear advantages in terms of convenience, reach, and scalability with using mobile technologies (including JITAIs) to support healthy behavior change, their clinical utility in care partners remains untested. Furthermore, although much research on care partners has focused on a one-size-fits-all approach to assessment and treatment, there is a growing body of evidence to suggest that although there are many commonalities in the care partner experience, there are aspects of care that are inherently unique to different care partner groups [
- ]. This study will provide preliminary data that will allow us to begin to explore the commonalities and differences among different populations, specifically care partners (1) caring for a person with a chronic condition that was caused by a traumatic event; (2) caring for a person with a progressive, fatal neurodegenerative disease; and (3) caring for a person with an episodic cancer condition that requires intense, prolonged inpatient and outpatient treatment. These diverse care partner groups not only allow for important between-population comparisons that can be used to inform future trial designs and maximize their impact but also maximize the generalizability to other care partner populations.Conclusions
In summary, at the conclusion of this project, we will have established the acceptability and feasibility of a low-cost, low-burden self-management intervention to improve HRQOL for care partners of persons across 3 diverse groups of care partners. Ultimately, these pilot data will also provide justification for a larger clinical trial designed to examine the effectiveness of a JITAI in a larger cohort of diverse care partners (ie, those caring for individuals who have survived a disabling traumatic event, are experiencing progressive neurological disease, or episodic cancer conditions). It is our hope that this work will ultimately lead to improved HRQOL of care partners and those they care for.
Acknowledgments
This work was supported by grant numbers R01NR013658 from the National Institutes of Health, National Institute of Nursing Research; R01HL146354 from the National Heart, Lung and Blood Institute; and UL1TR002240 from the National Center for Advancing Translational Sciences. The authors thank the investigators, coordinators, research associates, and assistants who worked on this study and the study participants and organizations who supported the recruitment efforts.
Authors' Contributions
NEC provided the first draft of the manuscript, and SWC and SS critically scrutinized the first draft and provided comments. ZW gave specific inputs to sample size considerations and statistical analysis plans, and JAM and AKL gave specific input to the description of the data storage and data storage system function. NEC, SWC, JAM, and SS designed the process evaluation. All authors participated in the design and content of the randomized controlled trial, and all authors read, commented on, and approved the final manuscript before submission.
Conflicts of Interest
None declared.
References
- Kreutzer JS, Gervasio AH, Camplair PS. Primary caregivers' psychological status and family functioning after traumatic brain injury. Brain Inj 1994 Apr 03;8(3):197-210. [CrossRef] [Medline]
- Hall KM, Karzmark P, Stevens M, Englander J, O'Hare P, Wright J. Family stressors in traumatic brain injury: a two-year follow-up. Arch Phys Med Rehabil 1994 Aug;75(8):876-884. [CrossRef] [Medline]
- Panting A, Merry P. The long term rehabilitation of severe head injuries with particular reference to the need for social and medical support for the patient's family. Rehabilitation 1972;38:33-37 [FREE Full text]
- Marsh NV, Kersel DA, Havill JH, Sleigh JW. Caregiver burden at 6 months following severe traumatic brain injury. Brain Inj 1998 Mar 03;12(3):225-238. [CrossRef] [Medline]
- Livingston MG, Brooks DN, Bond MR. Patient outcome in the year following severe head injury and relatives' psychiatric and social functioning. J Neurol Neurosurg Psychiatry 1985 Sep 01;48(9):876-881 [FREE Full text] [CrossRef] [Medline]
- Saban KL, Griffin JM, Urban A, Janusek MA, Pape TL, Collins E. Perceived health, caregiver burden, and quality of life in women partners providing care to Veterans with traumatic brain injury. J Rehabil Res Dev 2016;53(6):681-692 [FREE Full text] [CrossRef] [Medline]
- Carlozzi NE, Brickell TA, French LM, Sander A, Kratz AL, Tulsky DS, et al. Caring for our wounded warriors: A qualitative examination of health-related quality of life in caregivers of individuals with military-related traumatic brain injury. J Rehabil Res Dev 2016;53(6):669-680 [FREE Full text] [CrossRef] [Medline]
- Knight RG, Devereux R, Godfrey HP. Caring for a family member with a traumatic brain injury. Brain Inj 1998 Jul 03;12(6):467-481. [CrossRef] [Medline]
- Marsh NV, Kersel DA, Havill JH, Sleigh JW. Caregiver burden during the year following severe traumatic brain injury. J Clin Exp Neuropsychol 2002 Jun 09;24(4):434-447. [CrossRef] [Medline]
- Arango-Lasprilla J, Nicholls E, Cabrera TV, Drew A, Jimenez-Maldonado M, Martinez-Cortes M. Health-related quality of life in caregivers of individuals with traumatic brain injury from Guadalajara, Mexico. J Rehabil Med 2011 Nov;43(11):983-986 [FREE Full text] [CrossRef] [Medline]
- McPherson K, Pentland B, McNaughton H. Brain injury - the perceived health of carers. Disabil Rehabil 2000 Oct 15;22(15):683-689. [CrossRef] [Medline]
- Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry 1994 Aug;151(8):1172-1180. [CrossRef] [Medline]
- Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2003(1):CD003161. [CrossRef] [Medline]
- Carlozzi NE, Kratz AL, Sander AM, Chiaravalloti ND, Brickell TA, Lange RT, et al. Health-related quality of life in caregivers of individuals with traumatic brain injury: development of a conceptual model. Arch Phys Med Rehabil 2015 Jan;96(1):105-113 [FREE Full text] [CrossRef] [Medline]
- Ponsford J, Schönberger M. Family functioning and emotional state two and five years after traumatic brain injury. J Int Neuropsychol Soc 2010 Mar;16(2):306-317. [CrossRef] [Medline]
- Brooks N, Campsie L, Symington C, Beattie A, McKinlay W. The five year outcome of severe blunt head injury: a relative's view. J Neurol Neurosurg Psychiatry 1986 Jul 01;49(7):764-770 [FREE Full text] [CrossRef] [Medline]
- Brooks N, Campsie L, Symington C, Beattie A, McKinlay W. The effects of severe head injury on patient and relative within seven years of injury. J Head Trauma Rehabil 1987;2(3):1-13. [CrossRef]
- Kreutzer JS, Rapport LJ, Marwitz JH, Harrison-Felix C, Hart T, Glenn M, et al. Caregivers' well-being after traumatic brain injury: a multicenter prospective investigation. Arch Phys Med Rehabil 2009 Jun;90(6):939-946. [CrossRef] [Medline]
- Gillen R, Tennen H, Affleck G, Steinpreis R. Distress, depressive symptoms, and depressive disorder among caregivers of patients with brain injury. J Head Trauma Rehabil 1998 Jun;13(3):31-43. [CrossRef] [Medline]
- Winstanley J, Simpson G, Tate R, Myles B. Early indicators and contributors to psychological distress in relatives during rehabilitation following severe traumatic brain injury: findings from the Brain Injury Outcomes Study. J Head Trauma Rehabil 2006;21(6):453-466. [CrossRef] [Medline]
- Pickett T, Altmaier E, Paulsen JS. Caregiver burden in Huntington's disease. Rehabil Psychol 2007;52(3):311-318. [CrossRef]
- Bevans MF, Mitchell SA, Marden S. The symptom experience in the first 100 days following allogeneic hematopoietic stem cell transplantation (HSCT). Support Care Cancer 2008 Nov 6;16(11):1243-1254 [FREE Full text] [CrossRef] [Medline]
- Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Kilbourn K, Spradley J, Grzywa-Cobb R, et al. Elevated peri-transplant distress in caregivers of allogeneic blood or marrow transplant patients. Psychooncology 2013 Sep 25;22(9):2064-2070 [FREE Full text] [CrossRef] [Medline]
- Applebaum AJ, Bevans M, Son T, Evans K, Hernandez M, Giralt S, et al. A scoping review of caregiver burden during allogeneic HSCT: lessons learned and future directions. Bone Marrow Transplant 2016 Nov 13;51(11):1416-1422 [FREE Full text] [CrossRef] [Medline]
- Foxall MJ, Gaston-Johansson F. Burden and health outcomes of family caregivers of hospitalized bone marrow transplant patients. J Adv Nurs 1996 Nov;24(5):915-923. [CrossRef] [Medline]
- Jumisko E, Lexell J, Söderberg S. Living with moderate or severe traumatic brain injury: the meaning of family members' experiences. J Fam Nurs 2007 Aug 24;13(3):353-369. [CrossRef] [Medline]
- Peters LC, Stambrook M, Moore AD, Esses L. Psychosocial sequelae of closed head injury: effects on the marital relationship. Brain Inj 1990 Jul 03;4(1):39-47. [CrossRef] [Medline]
- Wood RL, Yurdakul LK. Change in relationship status following traumatic brain injury. Brain Inj 1997 Jul;11(7):491-501. [Medline]
- Kozloff R. Networks of social support and the outcome from severe head injury. J Head Trauma Rehabil 1987;2(3):14-23. [CrossRef]
- Caregivers of Veterans – serving on the homefront : report of study findings. National Alliance for Caregiving. 2010. URL: https://www.unitedhealthgroup.com/content/dam/UHG/PDF/uhf/caregivers-of-veterans-summary.pdf [accessed 2021-11-08]
- Lester P, Peterson K, Reeves J, Knauss L, Glover D, Mogil C, et al. The long war and parental combat deployment: effects on military children and at-home spouses. J Am Acad Child Adolesc Psychiatry 2010 Apr;49(4):310-320 [FREE Full text] [Medline]
- Ruff RL, Ruff SS, Wang X. Improving sleep: initial headache treatment in OIF/OEF veterans with blast-induced mild traumatic brain injury. J Rehabil Res Dev 2009;46(9):1071-1084 [FREE Full text] [CrossRef] [Medline]
- Taft CT, Schumm JA, Panuzio J, Proctor SP. An examination of family adjustment among Operation Desert Storm veterans. J Consult Clin Psychol 2008 Aug;76(4):648-656. [CrossRef] [Medline]
- Mansfield AJ, Kaufman JS, Marshall SW, Gaynes BN, Morrissey JP, Engel CC. Deployment and the use of mental health services among U.S. Army wives. N Engl J Med 2010 Jan 14;362(2):101-109. [CrossRef] [Medline]
- Jacobs HE. The Los Angeles Head Injury Survey: procedures and initial findings. Arch Phys Med Rehabil 1988 Jun;69(6):425-431. [Medline]
- McCabe MP, Firth L, O'Connor E. A comparison of mood and quality of life among people with progressive neurological illnesses and their caregivers. J Clin Psychol Med Settings 2009 Dec 29;16(4):355-362. [CrossRef] [Medline]
- O'Connor EJ, McCabe MP. Predictors of quality of life in carers for people with a progressive neurological illness: a longitudinal study. Qual Life Res 2011 Jun 2;20(5):703-711. [CrossRef] [Medline]
- Roscoe LA, Corsentino E, Watkins S, McCall M, Sanchez-Ramos J. Well-being of family caregivers of persons with late-stage Huntington's disease: lessons in stress and coping. Health Commun 2009 Apr 08;24(3):239-248. [CrossRef] [Medline]
- Aubeeluck A. Caring for the carers: quality of life in Huntington's disease. Br J Nurs 2005 Apr;14(8):452-454. [CrossRef] [Medline]
- Aubeeluck AV, Buchanan H, Stupple EJ. 'All the burden on all the carers': exploring quality of life with family caregivers of Huntington's disease patients. Qual Life Res 2012 Oct 13;21(8):1425-1435. [CrossRef] [Medline]
- Cox M. Quality of life among carers of people with Huntington’s disease. Br J Neurosci Nurs 2012 Oct;8(5):288-294. [CrossRef]
- Northouse LL, Katapodi MC, Schafenacker AM, Weiss D. The impact of caregiving on the psychological well-being of family caregivers and cancer patients. Semin Oncol Nurs 2012 Nov;28(4):236-245 [FREE Full text] [CrossRef] [Medline]
- Bevans M, Sternberg EM. Caregiving burden, stress, and health effects among family caregivers of adult cancer patients. J Am Med Assoc 2012 Jan 25;307(4):398-403 [FREE Full text] [CrossRef] [Medline]
- Stenberg U, Ruland CM, Miaskowski C. Review of the literature on the effects of caring for a patient with cancer. Psychooncology 2010 Oct 14;19(10):1013-1025. [CrossRef] [Medline]
- Ready RE, Mathews M, Leserman A, Paulsen JS. Patient and caregiver quality of life in Huntington's disease. Mov Disord 2008 Apr 15;23(5):721-726 [FREE Full text] [CrossRef] [Medline]
- Anderson VA, Catroppa C, Haritou F, Morse S, Pentland L, Rosenfeld J, et al. Predictors of acute child and family outcome following traumatic brain injury in children. Pediatr Neurosurg 2001 Mar 2;34(3):138-148. [CrossRef] [Medline]
- Sander AM, Caroselli JS, High WM, Becker C, Neese L, Scheibel R. Relationship of family functioning to progress in a post-acute rehabilitation programme following traumatic brain injury. Brain Inj 2002 Aug 03;16(8):649-657. [CrossRef] [Medline]
- Temple JL, Struchen MA, Pappadis MR. Impact of pre-injury family functioning and resources on self-reported post-concussive symptoms and functional outcomes in persons with mild TBI. Brain Inj 2016 Oct 14;30(13-14):1672-1682. [CrossRef] [Medline]
- Holland JN, Schmidt AT. Static and dynamic factors promoting resilience following traumatic brain injury: a brief review. Neural Plast 2015;2015:902802 [FREE Full text] [CrossRef] [Medline]
- Schönberger M, Ponsford J, Olver J, Ponsford M. A longitudinal study of family functioning after TBI and relatives' emotional status. Neuropsychol Rehabil 2010 Dec;20(6):813-829. [CrossRef] [Medline]
- Ramkumar NA, Elliott TR. Family caregiving of persons following neurotrauma: issues in research, service and policy. NeuroRehabilitation 2010;27(1):105-112 [FREE Full text] [CrossRef] [Medline]
- Kreutzer J, Marwitz JH, Godwin EE, Arango-Lasprilla JC. Practical approaches to effective family intervention after brain injury. J Head Trauma Rehabil 2010;25(2):113-120. [CrossRef] [Medline]
- Vangel S, Rapport LJ, Hanks RA. Effects of family and caregiver psychosocial functioning on outcomes in persons with traumatic brain injury. J Head Trauma Rehabil 2011;26(1):20-29. [CrossRef] [Medline]
- Sander AM, Maestas KL, Sherer M, Malec JF, Nakase-Richardson R. Relationship of caregiver and family functioning to participation outcomes after postacute rehabilitation for traumatic brain injury: a multicenter investigation. Arch Phys Med Rehabil 2012 May;93(5):842-848. [CrossRef] [Medline]
- Smith A, Schwirian PM. The relationship between caregiver burden and TBI survivors' cognition and functional ability after discharge. Rehabil Nurs 1998;23(5):252-257. [CrossRef] [Medline]
- Florian V, Katz S, Lahav V. Impact of traumatic brain damage on family dynamics and functioning: a review. Brain Inj 1989 Jul 03;3(3):219-233. [CrossRef] [Medline]
- McLaughlin A, Carey JL. The adversarial alliance: developing therapeutic relationships between families and the team in brain injury rehabilitation. Brain Inj 1993 Jul 03;7(1):45-51. [CrossRef] [Medline]
- Pelletier P, Alfano D. Depression, social support, and family coping following traumatic brain injury. Brain Cogn 2000 Oct;44(1):45-49. [CrossRef]
- Sady MD, Sander AM, Clark AN, Sherer M, Nakase-Richardson R, Malec JF. Relationship of preinjury caregiver and family functioning to community integration in adults with traumatic brain injury. Arch Phys Med Rehabil 2010 Oct;91(10):1542-1550. [CrossRef] [Medline]
- Barata A, Wood WA, Choi SW, Jim HS. Unmet needs for psychosocial care in hematologic malignancies and hematopoietic cell transplant. Curr Hematol Malig Rep 2016 Aug 25;11(4):280-287. [CrossRef] [Medline]
- Rohleder N, Marin TJ, Ma R, Miller GE. Biologic cost of caring for a cancer patient: dysregulation of pro- and anti-inflammatory signaling pathways. J Clin Oncol 2009 Jun 20;27(18):2909-2915. [CrossRef] [Medline]
- Shaffer KM, Kim Y, Carver CS, Cannady RS. Effects of caregiving status and changes in depressive symptoms on development of physical morbidity among long-term cancer caregivers. Health Psychol 2017 Aug;36(8):770-778 [FREE Full text] [CrossRef] [Medline]
- Kent EE, Rowland JH, Northouse L, Litzelman K, Chou WS, Shelburne N, et al. Caring for caregivers and patients: research and clinical priorities for informal cancer caregiving. Cancer 2016 Jul 01;122(13):1987-1995 [FREE Full text] [CrossRef] [Medline]
- Cancer caregiving in the U. S.: an intense, episodic, and challenging care experience. National Alliance for Caregiving, in partnership with the National Cancer Institute and the Cancer Support Community. 2016. URL: https://www.caregiving.org/wp-content/uploads/2020/05/CancerCaregivingReport_FINAL_June-17-2016.pdf [accessed 2021-10-27]
- Hurria A, Naylor M, Cohen HJ. Improving the quality of cancer care in an aging population: recommendations from an IOM report. J Am Med Assoc 2013 Nov 06;310(17):1795-1796. [CrossRef] [Medline]
- Cotner B, Carlozzi N, Lange R, Louis F, O’Connor D, Nakase-Richardson R, et al. Quality of sleep in caregivers of service members and veterans with traumatic brain injury. Arch Phys Med Rehabil 2017 Oct;98(10):97-98. [CrossRef]
- Johnson MD, Contrino A, Contrino J, Maxwell K, Leonard G, Kreutzer D. Murine model of otitis media with effusion: immunohistochemical demonstration of IL-1 alpha antigen expression. Laryngoscope 1994 Sep;104(9):1143-1149. [CrossRef] [Medline]
- Banaszkiewicz K, Sitek EJ, Rudzińska M, Sołtan W, Sławek J, Szczudlik A. Huntington's disease from the patient, caregiver and physician's perspectives: three sides of the same coin? J Neural Transm (Vienna) 2012 Nov 8;119(11):1361-1365 [FREE Full text] [CrossRef] [Medline]
- Wells R, Dywan J, Dumas J. Life satisfaction and distress in family caregivers as related to specific behavioural changes after traumatic brain injury. Brain Inj 2005 Dec 03;19(13):1105-1115. [CrossRef] [Medline]
- Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, et al. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: key components and design principles for ongoing health behavior support. Ann Behav Med 2018 May 18;52(6):446-462 [FREE Full text] [CrossRef] [Medline]
- Nahum-Shani I, Hekler EB, Spruijt-Metz D. Building health behavior models to guide the development of just-in-time adaptive interventions: a pragmatic framework. Health Psychol 2015 Dec;34S(Suppl):1209-1219 [FREE Full text] [CrossRef] [Medline]
- Ben-Zeev D, Brenner CJ, Begale M, Duffecy J, Mohr DC, Mueser KT. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophr Bull 2014 Nov 08;40(6):1244-1253 [FREE Full text] [CrossRef] [Medline]
- Riley W, Obermayer J, Jean-Mary J. Internet and mobile phone text messaging intervention for college smokers. J Am Coll Health 2008;57(2):245-248. [CrossRef] [Medline]
- Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, et al. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet 2011 Jul 02;378(9785):49-55 [FREE Full text] [CrossRef] [Medline]
- Mirowski M, Reid PR, Mower MM, Watkins L, Gott VL, Schauble JF, et al. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med 1980 Aug 07;303(6):322-324. [CrossRef] [Medline]
- Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008 Oct 02;359(14):1464-1476. [CrossRef] [Medline]
- Hanauer DA, Mei Q, Law J, Khanna R, Zheng K. Supporting information retrieval from electronic health records: a report of University of Michigan's nine-year experience in developing and using the Electronic Medical Record Search Engine (EMERSE). J Biomed Inform 2015 Jun;55:290-300 [FREE Full text] [CrossRef] [Medline]
- Dimidjian S, Barrera M, Martell C, Muñoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol 2011 Apr 27;7(1):1-38. [CrossRef] [Medline]
- Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, et al. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol 2006 Aug;74(4):658-670. [CrossRef] [Medline]
- Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, et al. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol 1996 Apr;64(2):295-304. [CrossRef] [Medline]
- Mazzucchelli T, Kane R, Rees C. Behavioral activation treatments for depression in adults: a meta-analysis and review. Clin Psychol Sci Pract 2009 Dec;16(4):383-411. [CrossRef]
- Hart T, Vaccaro M, Collier G, Chervoneva I, Fann JR. Promoting mental health in traumatic brain injury using single-session Behavioural Activation and SMS messaging: a randomized controlled trial. Neuropsychol Rehabil 2020 Sep 14;30(8):1523-1542. [CrossRef] [Medline]
- Gawrysiak M, Nicholas C, Hopko DR. Behavioral activation for moderately depressed university students: randomized controlled trial. J Counsel Psychol 2009 Jul;56(3):468-475. [CrossRef]
- Hopko DR, Lejuez CW, Hopko SD. Behavioral activation as an intervention for coexistent depressive and anxiety symptoms. Clin Case Stud 2016 Jul 21;3(1):37-48. [CrossRef]
- Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. J Gerontol 1989 May 01;44(3):61-71. [CrossRef] [Medline]
- Struchen MA, Atchison TB, Roebuck TM, Caroselli JS, Sander AM. A multidimensional measure of caregiving appraisal: validation of the Caregiver Appraisal Scale in traumatic brain injury. J Head Trauma Rehabil 2002 Apr;17(2):132-154. [CrossRef] [Medline]
- No authors listed. Unified Huntington's Disease Rating Scale: reliability and consistency. Huntington Study Group. Mov Disord 1996 Mar;11(2):136-142. [CrossRef] [Medline]
- Carlozzi NE, Boileau NR, Perlmutter JS, Chou KL, Stout JC, Paulsen JS, et al. Agreement between clinician-rated versus patient-reported outcomes in Huntington disease. J Neurol 2018 Jun 23;265(6):1443-1453 [FREE Full text] [CrossRef] [Medline]
- Boake C. Supervision rating scale: a measure of functional outcome from brain injury. Arch Phys Med Rehabil 1996 Aug;77(8):765-772. [CrossRef]
- Carlozzi NE, Kallen MA, Hanks R, Hahn EA, Brickell TA, Lange RT, et al. The TBI-CareQOL Measurement System: development and preliminary validation of health-related quality of life measures for caregivers of civilians and service members/veterans with traumatic brain injury. Arch Phys Med Rehabil 2019 Apr;100(4S):1-12 [FREE Full text] [CrossRef] [Medline]
- Carlozzi NE, Kallen MA, Ianni PA, Hahn EA, French LM, Lange RT, et al. The development of a new computer-adaptive test to evaluate strain in caregivers of individuals with TBI: TBI-CareQOL Caregiver Strain. Arch Phys Med Rehabil 2019 Apr;100(4S):13-21 [FREE Full text] [CrossRef] [Medline]
- Carlozzi NE, Lange RT, French LM, Sander AM, Ianni PA, Tulsky DS, et al. Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: reliability and validity data for the TBI-CareQOL Measurement System. Arch Phys Med Rehabil 2019 Apr;100(4S):85-93 [FREE Full text] [CrossRef] [Medline]
- Carlozzi NE, Kallen MA, Sander AM, Brickell TA, Lange RT, French LM, et al. The development of a new computer adaptive test to evaluate anxiety in caregivers of individuals with traumatic brain injury: TBI-CareQOL Caregiver-Specific Anxiety. Arch Phys Med Rehabil 2019 Apr;100(4S):22-30 [FREE Full text] [CrossRef] [Medline]
- Buysse D, Yu L, Moul DE, Germain A, Stover A, Dodds NE, et al. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep 2010 Jun;33(6):781-792 [FREE Full text] [CrossRef] [Medline]
- Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care 2007 May;45(5 Suppl 1):3-11 [FREE Full text] [CrossRef] [Medline]
- Bartlett SJ, Orbai A, Duncan T, DeLeon E, Ruffing V, Clegg-Smith K, et al. Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS One 2015 Sep 17;10(9):e0138543 [FREE Full text] [CrossRef] [Medline]
- Quach CW, Langer MM, Chen RC, Thissen D, Usinger DS, Emerson MA, et al. Reliability and validity of PROMIS measures administered by telephone interview in a longitudinal localized prostate cancer study. Qual Life Res 2016 Nov 30;25(11):2811-2823 [FREE Full text] [CrossRef] [Medline]
- Kappelman MD, Long MD, Martin C, DeWalt DA, Kinneer PM, Chen W, et al. Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 2014 Aug;12(8):1315-1323 [FREE Full text] [CrossRef] [Medline]
- Bajaj J, Thacker LR, Wade JB, Sanyal AJ, Heuman DM, Sterling RK, et al. PROMIS computerised adaptive tests are dynamic instruments to measure health-related quality of life in patients with cirrhosis. Aliment Pharmacol Ther 2011 Nov;34(9):1123-1132 [FREE Full text] [CrossRef] [Medline]
- Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol 2010 Nov;63(11):1179-1194 [FREE Full text] [CrossRef] [Medline]
- Cook KF, Jensen SE, Schalet BD, Beaumont JL, Amtmann D, Czajkowski S, et al. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol 2016 May;73:89-102 [FREE Full text] [CrossRef] [Medline]
- Cella D, Lai J, Jensen SE, Christodoulou C, Junghaenel DU, Reeve BB, et al. PROMIS fatigue item bank had clinical validity across diverse chronic conditions. J Clin Epidemiol 2016 May;73:128-134 [FREE Full text] [CrossRef] [Medline]
- Kratz AL, Schilling S, Goesling J, Williams DA. The PROMIS FatigueFM Profile: a self-report measure of fatigue for use in fibromyalgia. Qual Life Res 2016 Jul 28;25(7):1803-1813 [FREE Full text] [CrossRef] [Medline]
- Cook KF, Bamer AM, Roddey TS, Kraft GH, Kim J, Amtmann D. A PROMIS fatigue short form for use by individuals who have multiple sclerosis. Qual Life Res 2012 Aug 17;21(6):1021-1030 [FREE Full text] [CrossRef] [Medline]
- Tulsky D, Kisala PA, Victorson D, Carlozzi N, Bushnik T, Sherer M, et al. TBI-QOL: development and calibration of item banks to measure patient reported outcomes following traumatic brain injury. J Head Trauma Rehabil 2016;31(1):40-51 [FREE Full text] [CrossRef] [Medline]
- Purvis T, Andreou E, Neuman BJ, Riley LH, Skolasky RL. Concurrent validity and responsiveness of PROMIS health domains among patients presenting for anterior cervical spine surgery. Spine (Phila Pa 1976) 2017 Dec 01;42(23):1357-1365. [CrossRef] [Medline]
- Carlozzi NE, Ianni PA, Tulsky DS, Brickell TA, Lange RT, French LM, et al. Understanding health-related quality of life in caregivers of civilians and service members/veterans with traumatic brain injury: establishing the reliability and validity of PROMIS fatigue and sleep disturbance item banks. Arch Phys Med Rehabil 2019 Apr;100(4S):102-109 [FREE Full text] [CrossRef] [Medline]
- Carlozzi NE, Hanks R, Lange RT, Brickell TA, Ianni PA, Miner JA, et al. Understanding health-related quality of life in caregivers of civilians and service members/veterans with traumatic brain injury: establishing the reliability and validity of PROMIS mental health measures. Arch Phys Med Rehabil 2019 Apr;100(4S):94-101 [FREE Full text] [CrossRef] [Medline]
- Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res 2014 Sep;56:112-119 [FREE Full text] [CrossRef] [Medline]
- Salsman JM, Butt Z, Pilkonis PA, Cyranowski JM, Zill N, Hendrie HC, et al. Emotion assessment using the NIH Toolbox. Neurology 2013 Mar 12;80(11 Suppl 3):S76-S86 [FREE Full text] [CrossRef] [Medline]
- Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS measures of self-efficacy for managing chronic conditions. Qual Life Res 2017 Jul 26;26(7):1915-1924 [FREE Full text] [CrossRef] [Medline]
- Carlozzi N, Goodnight S, Casaletto KB, Goldsmith A, Heaton RK, Wong AW, et al. Validation of the NIH Toolbox in individuals with neurologic disorders. Arch Clin Neuropsychol 2017 Aug 01;32(5):555-573 [FREE Full text] [CrossRef] [Medline]
- Salsman JM, Victorson D, Choi SW, Peterman AH, Heinemann AW, Nowinski C, et al. Development and validation of the positive affect and well-being scale for the neurology quality of life (Neuro-QOL) measurement system. Qual Life Res 2013 Nov 23;22(9):2569-2580 [FREE Full text] [CrossRef] [Medline]
- Allen J, Alpass FM, Stephens CV. The sensitivity of the MOS SF-12 and PROMIS® global summary scores to adverse health events in an older cohort. Qual Life Res 2018 Aug 3;27(8):2207-2215. [CrossRef] [Medline]
- Kasturi S, Szymonifka J, Burket JC, Berman JR, Kirou KA, Levine AB, et al. Feasibility, validity, and reliability of the 10-item patient reported outcomes measurement information system global health short form in outpatients with systemic lupus erythematosus. J Rheumatol 2018 Mar 01;45(3):397-404 [FREE Full text] [CrossRef] [Medline]
- Katzan IL, Lapin B. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study. Stroke 2018 Jan;49(1):147-154. [CrossRef] [Medline]
- Lapin B, Thompson NR, Schuster A, Katzan IL. Clinical Utility of Patient-Reported Outcome Measurement Information System Domain Scales. Circ Cardiovasc Qual Outcomes 2019 Jan;12(1):e004753. [CrossRef] [Medline]
- Stoop N, Menendez ME, Mellema JJ, Ring D. The PROMIS Global Health Questionnaire correlates with the QuickDASH in patients with upper extremity illness. Hand (N Y) 2018 Jan 13;13(1):118-121 [FREE Full text] [CrossRef] [Medline]
- Schulz K, Altman D, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010 Mar 23;340:c332 [FREE Full text] [CrossRef] [Medline]
- Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. J Am Med Assoc 2013 Feb 27;309(8):814-822. [CrossRef] [Medline]
- Schulz K, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol 2010 May;115(5):1063-1070. [CrossRef] [Medline]
- Caregiver statistics: demographics. Caregiver Resource. 2019. URL: https://www.caregiver.org/caregiver-statistics-demographics [accessed 2021-11-04]
- Reinhard SC, Given B, Petlick NH, Bemis A. Supporting family caregivers in providing care. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and Quality and U.S. Department of Health and Human Services; 2008.
- Talley RC, Crews JE. Framing the public health of caregiving. Am J Public Health 2007 Feb;97(2):224-228. [CrossRef] [Medline]
Abbreviations
CFR: Code of Federal Regulations |
CONSORT: Consolidated Standards of Reporting Trials |
EMA: ecological momentary assessment |
HCT: hematopoietic cell transplantation |
HD: Huntington disease |
HRQOL: health-related quality of life |
JITAI: just-in-time adaptive intervention |
PROMIS: Patient-Reported Outcomes Measurement Information System |
REDCap: Research Electronic Data Capture |
SCI: spinal cord injury |
Edited by G Eysenbach; submitted 11.08.21; peer-reviewed by M Raj, W Wood; comments to author 23.09.21; revised version received 07.10.21; accepted 07.10.21; published 09.12.21
Copyright©Noelle E Carlozzi, Sung Won Choi, Zhenke Wu, Jennifer A Miner, Angela K Lyden, Christopher Graves, Jitao Wang, Srijan Sen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.12.2021.
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