JMIR Publications

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  RCTs - Protocols/Proposals (non-eHealth)

  Aug 14, 2020

  The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Mahesh Karra  
  • David Canning  

  Abstract:

  Background: The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. Objective: This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. Methods: Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. Results: A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. Conclusions: The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women’s well-being. Trial Registration: American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320

  • JMIR Res Protoc 2020;9(8):e16697

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  Non-Randomized Study Protocols and...

  Aug 14, 2020

  Improving Airways Patency and Ventilation Through Optimal Positive Pressure Identified by Noninvasive Mechanical Ventilation Titration in Mounier-Kuhn...

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  Authors List:

  • Evelise Lima  
  • Maria Aparecida Miyuki Nakamura  
  • Pedro Rodrigues Genta  
  • Ascedio José Rodrigues  
  • Rodrigo Abensur Athanazio  
  • Samia Rached  
  • Eduardo Leite Vieira Costa  
  • Rafael Stelmach  

  Abstract:

  Background: Mounier-Kuhn syndrome or congenital tracheobronchomegaly is a rare disease characterized by dilation of the trachea and the main bronchi within the thoracic cavity. The predominant signs and symptoms of the disease include coughing, purulent and abundant expectoration, dyspnea, snoring, wheezing, and recurrent respiratory infection. Symptoms of the disease in some patients are believed to be pathological manifestations arising due to resident tracheobronchomalacia. Although treatment options used for the management of this disease include inhaled bronchodilators, corticosteroids, and hypertonic solution, there is no consensus on the treatment. The use of continuous positive airway pressure (CPAP) has been reported as a potential therapeutic option for tracheobronchomalacia, but no prospective studies have demonstrated its efficacy in this condition. Objective: The purpose of this is to identify the presence of tracheobronchomalacia and an optimal CPAP pressure that reduces the tracheobronchial collapse in patients with Mounier-Kuhn syndrome and to analyze the repercussion in pulmonary ventilation. In parallel, we aim to evaluate the prevalence of obstructive sleep apnea/hypopnea syndrome. Methods: This interventional, open-label, single-arm clinical trial will enroll patients who are diagnosed Mounier-Kuhn syndrome. Patient evaluation will be conducted in an outpatient clinic and involve 3 visits. Visit 1 will involve the collection and registration of social demographic, clinical, and functional data. Visit 2 will entail polysomnography, bronchoscopy for the evaluation of tracheobronchomalacia, titration of the optimal pressure that reduces the degree of collapse of the airway, and electrical impedance tomography. In visit 3, patients exhibiting a reduction in collapse areas will be requested to undergo chest computed tomography during inspiration and forced expiration with and without positive pressure (titrated to determine optimal CPAP pressure). Results: This protocol is a doctorate project. The project was submitted to the institutional review board on January 24, 2017, and approval was granted on February 2, 2017 (Brazilian Research database number CAAE 64001317.4.000.0068). Patient evaluations started in April 2018. Planned recruitment is based on volunteers’ availability and clinical stability, and interventions will be conducted at least once a month to finish the project at the end of 2020. A preliminary analysis of each case will be performed after each intervention, but detailed results are expected to be reported in the first quarter of 2021. Conclusions: There is no consensus on the best treatment options for managing Mounier-Kuhn syndrome. The use of positive pressure could maintain patency of the collapsed airways, functioning as a “pneumatic stent” to reduce the degree of airflow obstruction. This, in turn, could promote mobilization of thoracic secretion and improve pulmonary ventilation. Trial Registration: ClinicalTrails.gov NCT03101059; https://clinicaltrials.gov/ct2/show/NCT03101059.

  • JMIR Res Protoc 2020;9(8):e14786

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  Non-Randomized Study Protocols and...

  Aug 14, 2020

  Personalized Approach Bias Modification Smartphone App (“SWIPE”) to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for...

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  Authors List:

  • Victoria Manning  
  • Hugh Piercy  
  • Joshua Benjamin Bernard Garfield  
  • Dan Ian Lubman  

  Abstract:

  Background: Alcohol accounts for 5.1% of the global burden of disease and injury, and approximately 1 in 10 people worldwide develop an alcohol use disorder. Approach bias modification (ABM) is a computerized cognitive training intervention in which patients are trained to “avoid” alcohol-related images and “approach” neutral or positive images. ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation). However, many people who drink at hazardous or harmful levels do not require residential treatment or choose not to access it (eg, owing to its cost, duration, inconvenience, or concerns about privacy). Smartphone app–delivered ABM could offer a free, convenient intervention to reduce cravings and consumption that is accessible regardless of time and place, and during periods when support is most needed. Importantly, an ABM app could also easily be personalized (eg, allowing participants to select personally relevant images as training stimuli) and gamified (eg, by rewarding participants for the speed and accuracy of responses) to encourage engagement and training completion. Objective: We aim to test the feasibility and acceptability of “SWIPE,” a gamified, personalized alcohol ABM smartphone app, assess its preliminary effectiveness, and explore in which populations the app shows the strongest indicators of effectiveness. Methods: We aim to recruit 500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking. Recruitment will be conducted through social media and websites. The participants’ intended alcohol use goal (reduction or abstinence), motivation to change their consumption, and confidence to change their consumption will be measured prior to training. Participants will be instructed to download the SWIPE app and complete at least 2 ABM sessions per week for 4 weeks. Recruitment and completion rates will be used to assess feasibility. Four weeks after downloading SWIPE, participants will be asked to rate SWIPE’s functionality, esthetics, and quality to assess acceptability. Alcohol consumption, craving, and dependence will be measured prior to commencing the first session of ABM and 4 weeks later to assess whether these variables change significantly over the course of ABM. Results: We expect to commence recruitment in August 2020 and complete data collection in March 2021. Conclusions: This will be the first study to test the feasibility, acceptability, and preliminary effectiveness of a personalized, gamified ABM intervention smartphone app for hazardous or harmful drinkers. Results will inform further improvements to the app, as well as the design of a statistically powered randomized controlled trial to test its efficacy relative to a control condition. Ultimately, we hope that SWIPE will extend the benefits of ABM to the millions of individuals who consume alcohol at hazardous levels and wish to reduce their use but cannot or choose not to access treatment. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000638932p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p

  • JMIR Res Protoc 2020;9(8):e21278

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  RCTs - Protocols/Proposals (eHealth)

  Aug 14, 2020

  App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized...

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  Authors List:

  • Stephanie Erika Bonn  
  • Mari Hult  
  • Kristina Spetz  
  • Marie Löf  
  • Ellen Andersson  
  • Mikael Wiren  
  • Ylva Trolle Lagerros  

  Abstract:

  Background: To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. Objective: The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. Methods: The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. Results: A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. Conclusions: Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. Trial Registration: ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464

  • JMIR Res Protoc 2020;9(8):e19624

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  Non-Randomized Study Protocols and...

  Aug 14, 2020

  Systemic Sentinel Lymph Node Detection Using Fluorescence Imaging After Indocyanine Green Intravenous Injection in Colorectal Cancer: Protocol for a...

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  Authors List:

  • Gabriel Liberale  
  • Sophie Vankerckhove  
  • Fikri Bouazza  
  • Maria Gomez Galdon  
  • Denis Larsimont  
  • Michel Moreau  
  • Pierre Bourgeois  
  • Vincent Donckier  

  Abstract:

  Background: Nodal staging is a major concern in colorectal cancer as it is an important prognostic factor. Several techniques that could potentially improve patient treatment and prognosis have been developed to increase the accuracy of nodal staging. Sentinel lymph node detection has been shown to accurately reflect nodal status in various tumors and has become the standard procedure in nodal staging of breast cancer and melanoma. However, in colorectal cancer, sentinel lymph node detection techniques are still controversial as the sensitivity reported in the literature varies from one study to another. Recently, indocyanine green fluorescence–guided surgery has been reported to be a useful technique for detection of macroscopic and microscopic metastatic deposits in lymph nodes after intravenous administration of indocyanine green dye. However, no studies have focused on the potential role of sentinel lymph node detection after systemic administration of indocyanine green dye, so-called systemic sentinel lymph nodes, or on the correspondence between the identification of the sentinel lymph node by standard local injection techniques and the detection of fluorescent lymph nodes with this new approach. Objective: The aim of this protocol is to validate the concept of sentinel lymph nodes identified by fluorescence imaging after intravenous injection of indocyanine green dye and to compare the sentinel lymph nodes identified by fluorescence imaging with sentinel lymph nodes detected by the standard blue dye technique. Methods: This study (SeLyNoFI; Sentinel Lymph Nodes Fluorescence Imaging) is a diagnostic, single-arm, open-label feasibility study, including patients with colorectal adenocarcinoma with or without metastatic disease who are admitted for elective colorectal resection of the primary tumor. This study evaluates the feasibility of a new approach for improving the accuracy of nodal staging using fluorescence imaging after intravenous administration of indocyanine green dye. Sensitivity, positive predictive value, and accuracy of the classical blue dye technique and of the investigatory fluorescence imaging technique will be calculated. Translational research will be proposed, if applicable. Results: As of June 2020, this study has been registered. Submission for ethical review is planned for September 2020. Conclusions: The potential correlation between the two different approaches to detect sentinel lymph nodes offers new strategies for improving the accuracy of nodal staging in colorectal cancer. This new concept of the systemic sentinel lymph node and a greater understanding of the interactions between systemic sentinel lymph nodes and standard sentinel lymph nodes may provide important information regarding the underlying mechanism of primary tumor lymphatic drainage. The enhanced permeability and retention effect can also play a role in the fluorescence of systemic sentinel lymph nodes, especially if these lymph nodes are inflamed. In this case, we can even imagine that this new technique will highlight more instances of lymph node–positive colorectal cancer.

  • JMIR Res Protoc 2020;9(8):e17976

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  Non-randomized Protocols and Methods...

  Aug 14, 2020

  Feasibility of the Internet Attachment–Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial

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  Authors List:

  • Daniel Campos  
  • Mayte Navarro-Gil  
  • Paola Herrera-Mercadal  
  • Laura Martínez-García  
  • Ausiàs Cebolla  
  • Luis Borao  
  • Yolanda López-Del-Hoyo  
  • Diana Castilla  
  • Eva del Río  
  • Javier García-Campayo  
  • Soledad Quero  

  Abstract:

  Background: Compassion-based interventions delivered over the internet are showing promising results for the promotion of psychological health and well-being. Several studies have highlighted their feasibility, acceptance, and preliminary efficacy. However, this is an incipient field of research, and to the best of our knowledge, there are no data available from Spanish-speaking countries. Objective: The aim of this study is to investigate the feasibility, acceptance, and preliminary efficacy of the Internet Attachment–Based Compassion Therapy (iABCT), a web-based version of the Attachment-Based Compassion Therapy, in Spanish speakers from the general population. Methods: This feasibility study features a single-arm, uncontrolled, within-group design with an embedded qualitative and quantitative process evaluation at baseline, immediately after the intervention and at the 3-month follow-up. A minimum of 35 participants from the general population will be allocated to iABCT. Feasibility measures will include attrition rate, patterns of use of the web-based system, and participants’ acceptability, usability, and opinion. The primary outcome was measured using the Pemberton Happiness Index. Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire). Mixed models will be used to evaluate primary and secondary outcome measures. A qualitative content analysis of the participants’ qualitative responses will also be performed. Results: Enrollment started in February 2020 and will be finished in April 2020. Data analysis will start in October 2020. Conclusions: To our knowledge, this study will, for the first time, show data on the feasibility, acceptability, and preliminary efficacy of web-based compassion (and self-compassion) training—that is, the adapted iABCT—in Spanish speakers from the general population. Further aspects of their implementation (ie, facilitators, barriers, and unwanted effects) and mechanisms of change will be investigated. This study will allow the revision and fine-tuning of the developed intervention, study design, and planning procedures, as well as the initiation of a future randomized controlled trial. Clinical Trial: Clinicaltrials.gov: NCT03918746. Registered on April 17, 2019. Protocol version 1, 6 March 2019.

  • JMIR Res Protoc 2020;9(8):e16717

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  Grant Proposals (funded, non-ehealth)

  Aug 13, 2020

  The Parenting Education Needs of Women Experiencing Incarceration in South Australia: Proposal for a Mixed Methods Study

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  Authors List:

  • Belinda Lovell  
  • Mary Steen  
  • Adrian Esterman  
  • Angela Brown  

  Abstract:

  Background: The mother-child relationship is extremely important, and for mothers experiencing incarceration, this relationship has unique challenges. There is limited evidence currently available to identify the type and content of parenting education that would best suit women who are incarcerated. Objective: This study aims to design and evaluate a parent education program for women experiencing incarceration in South Australia. The program must meet the specific needs of incarcerated women and considers the cultural needs of Aboriginal and or Torres Strait Islanders and migrant women. Hereafter Aboriginal and/or Torres Strait Islander peoples will be referred to as Aboriginal; the authors acknowledge the diversity within Aboriginal cultures. Methods: This study will utilize a mixed methods approach, including six phases framed by a community-based theoretical model. This methodology provides a collaborative approach between the researcher and the community to empower the women experiencing incarceration, allowing their parenting education needs to be addressed. Results: A scoping review was undertaken to inform this study protocol. This paper describes and discusses the protocol for this mixed methods study. Recruiting commenced in December 2019, results will be published in 2020, and the project will be completed by August 2022. This project has been supported by a Research Training Scholarship from the Australian Government. Conclusions: The scoping review highlighted a lack of rigorous evidence to determine the most appropriate parenting education program to suit women experiencing incarceration specifically, and there was little consideration for the cultural needs of women. It also became clear that when quantitative and qualitative data are utilized, the women’s voices can assist in the determination of what works, what will not work, and what can be improved. The data collected and analyzed during this study, as well as the current evidence, will assist in the development of a specific parenting education program to meet the needs of women experiencing incarceration in South Australia and will be implemented and evaluated as part of the study. Trial Registration:

  • JMIR Res Protoc 2020;9(8):e18992

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  Theme Issue (2018): Adolescent...

  Aug 13, 2020

  Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep)

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  Authors List:

  • Cathy J Reback  
  • Joshua A Rusow  
  • Demetria Cain  
  • David Benkeser  
  • Sean Arayasirikul  
  • Lisa Hightow-Weidman  
  • Keith J Horvath  

  Abstract:

  Background: Transgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection. Objective: This protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years). Methods: Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization. Results: Funding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021. Conclusions: By providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults. Trial Registration: ClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724

  • JMIR Res Protoc 2020;9(8):e18326

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  Proposals (eHealth)

  Aug 12, 2020

  Closing the COVID-19 Psychological Treatment Gap for Cancer Patients in Alberta: Protocol for the Implementation and Evaluation of Text4Hope-Cancer Care

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  Authors List:

  • Vincent Israel Opoku Agyapong  
  • Marianne Hrabok  
  • Reham Shalaby  
  • Kelly Mrklas  
  • Wesley Vuong  
  • April Gusnowski  
  • Shireen Surood  
  • Andrew James Greenshaw  
  • Nnamdi Nkire  

  Abstract:

  Background: Cancer diagnoses and treatments usually engender significant anxiety and depressive symptoms in patients, close relatives, and caregivers. Providing psychological support during the coronavirus disease (COVID-19) pandemic presents additional challenges due to self-isolation and social or physical distancing measures in place to limit viral spread. This protocol describes the use of text messaging (Text4Hope-Cancer Care) as a convenient, cost-effective, and accessible population-level mental health intervention. As demonstrated in previous research, this evidence-based program supports good outcomes and high user satisfaction. Objective: We will implement daily supportive text messaging as a way of reducing and managing anxiety and depression related to cancer diagnosis and treatment in Alberta, Canada. Prevalence of anxiety and depressive symptoms, their demographic correlates, and Text4Hope-Cancer Care–induced changes in anxiety and depression will be evaluated. Methods: Alberta residents with a cancer diagnosis and the close relatives of those dealing with a cancer diagnosis can self-subscribe to the Text4Hope-Cancer Care program by texting “CancerCare” to a dedicated text number. Self-administered, anonymous, online questionnaires will be used to assess anxiety and depressive symptoms using the Hospital Anxiety and Depression Scale (HADS). Data will be collected at onset from individuals receiving text messages, and at the mid- and endpoints of the program (ie, at 6 and 12 weeks, respectively). Data will be analyzed with parametric and nonparametric statistics for primary outcomes (ie, anxiety and depressive symptoms) and usage metrics, including the number of subscribers and user satisfaction. In addition, data mining and machine learning analysis will focus on determining subscriber characteristics that predict high levels of symptoms of mental disorders, and may subsequently predict changes in those measures in response to the Text4Hope-Cancer Care program. Results: The first research stage, which was completed in April 2020, involved the creation and review of the supportive text messages and uploading of messages into a web-based text messaging service. The second stage, involving the launch of the Text4Hope-Cancer Care program, occurred in May 2020. Conclusions: Text4Hope-Cancer Care has the potential to provide key information regarding the prevalence rates of anxiety and depressive symptoms in patients diagnosed or receiving care for cancer and their caregivers. The study will generate demographic correlates of anxiety and depression, and outcome data related to this scalable, population-level intervention. Information from this study will be valuable for health care practitioners working in cancer care and may help inform policy and decision making regarding psychological interventions for cancer care.

  • JMIR Res Protoc 2020;9(8):e20240

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  NIH funded proposals with peer-review...

  Aug 12, 2020

  Near-Infrared Cerebrovascular Reactivity for Monitoring Cerebral Autoregulation and Predicting Outcomes in Moderate to Severe Traumatic Brain Injury:...

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  Authors List:

  • Alwyn Gomez  
  • Joshua Dian  
  • Logan Froese  
  • Frederick Adam Zeiler  

  Abstract:

  Background: Impaired cerebrovascular reactivity after traumatic brain injury (TBI) in adults is emerging as an important prognostic factor, with strong independent association with 6-month outcomes. To date, it is unknown if impaired cerebrovascular reactivity during the acute phase is associated with ongoing impaired continuously measured cerebrovascular reactivity in the long-term, and if such measures are associated with clinical phenotype at those points in time. Objective: We describe a prospective pilot study to assess the use of near-infrared spectroscopy (NIRS) to derive continuous measures of cerebrovascular reactivity during the acute and long-term phases of TBI in adults. Methods: Over 2 years, we will recruit up to 80 adults with moderate/severe TBI admitted to the intensive care unit (ICU) with invasive intracranial pressure (ICP) monitoring. These patients will undergo high-frequency data capture of ICP, arterial blood pressure (ABP), and NIRS for the first 5 days of care. Patients will then have 30 minutes of noninvasive NIRS and ABP monitoring in the clinic at 3, 6, and 12 months post-injury. Outcomes will be assessed via the Glasgow Outcome Scale and Short Form-12 questionnaires. Various relationships between NIRS and ICP-derived cerebrovascular reactivity metrics and associated outcomes will be assessed using biomedical signal processing techniques and both multivariate and time-series statistical methodologies. Results: Study recruitment began at the end of February 2020, with data collection ongoing and three patients enrolled at the time of writing. The expected duration of data collection will be from February 2020 to January 2022, as per our local research ethics board approval (B2018:103). Support for this work has been obtained through the National Institutes of Health (NIH) through the National Institute of Neurological Disorders and Stroke (NINDS) (R03NS114335), funded in January 2020. Conclusions: With the application of NIRS technology for monitoring of patients with TBI, we expect to be able to outline core relationships between noninvasively measured aspects of cerebral physiology and invasive measures, as well as patient outcomes. Documenting these relationships carries the potential to revolutionize the way we monitor patients with TBI, moving to more noninvasive techniques.

  • JMIR Res Protoc 2020;9(8):e18740

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  RCTs - Protocols/Proposals (non-eHealth)

  Aug 12, 2020

  Effectiveness of Combining Organizational Alcohol Policy and Skills Training for Managers to Reduce Hazardous Alcohol Consumption in Swedish Workplaces:...

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  Authors List:

  • Devy Lysandra Elling  
  • Martina Wilson  
  • Per Carlbring  
  • Peter Wennberg  
  • Kristina Sundqvist  

  Abstract:

  Background: High alcohol consumption poses risks to individual health and society. Previous alcohol interventions have mainly focused on high-risk consumers or young adults in school-based settings. Since the majority of the adult population is in the workforce, the workplace can be considered a favorable arena for implementing interventions. Objective: This protocol describes a project aimed at increasing knowledge of the effectiveness of combining the implementation of an organizational alcohol policy with skills training for managers as a workplace alcohol prevention program, by evaluating the intervention and exploring managers’ perceptions of the intervention. Methods: Organizations with at least 100 employees were invited to take part in the project. A total of 11 organizations (744 managers and 11,761 employees) were included in the project. Data are collected through self-administered online surveys at baseline, 12 months, and 24 months. The primary outcome is managers’ inclination to initiate an early alcohol intervention (eg, by initiating a dialogue) when concern regarding employees’ hazardous alcohol consumption arises. The secondary outcomes of interest are managers’ and employees’ organizational alcohol policy knowledge and changes in alcohol consumption, as measured using the Alcohol Use Disorder Identification Test (AUDIT) score. A linear mixed-model framework will be used to model variability on different levels. Primary analysis will follow an intention-to-treat approach. Additionally, managers’ responses from semistructured interviews will be analyzed using thematic analysis to explore managers’ experiences regarding the prevention program. Results: This study is ongoing. The overall study start was on January 2018, and the study is planned to end in December 2020. Baseline and 12-month follow-up measurements have been collected. Conclusions: This project is designed to evaluate the effectiveness of an alcohol prevention program regarding higher inclination to initiate early alcohol interventions after policy implementation and skills training among managers, compared to the usual practices in the workplace. The results from this study can contribute to increased knowledge about alcohol interventions and future prevention programs in the workplace. Trial Registration: ISRCTN17250048; http://www.isrctn.com/ISRCTN17250048

  • JMIR Res Protoc 2020;9(8):e17145

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  RCTs - Protocols/Proposals (eHealth)

  Aug 11, 2020

  Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness...

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  Authors List:

  • Brian Mustanski  
  • David A Moskowitz  
  • Kevin O Moran  
  • Michael E Newcomb  
  • Kathryn Macapagal  
  • Carlos Rodriguez-Díaz  
  • H Jonathon Rendina  
  • Eric B Laber  
  • Dennis H Li  
  • Margaret Matson  
  • Ali J Talan  
  • Cynthia Cabral  

  Abstract:

  Background: Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth are. Objective: This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART. Methods: Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements. Results: The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing. Conclusions: SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices. Trial Registration: ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131

  • JMIR Res Protoc 2020;9(8):e19701

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