JMIR Publications

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  NIH funded proposals with peer-review...

  Jan 23, 2019

  A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression and/or Anxiety and Their Parents:...

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  Authors List:

  • Ana Radovic  
  • Yaming Li  
  • Douglas Landsittel  
  • Bradley D Stein  
  • Elizabeth Miller  

  Abstract:

  Background: Few adolescents who experience depression or anxiety connect to mental health treatment. Supporting Our Valued Adolescents (SOVA) is a stakeholder-informed technology intervention that consists of 2 blog-format websites—one for adolescents and another for parents. SOVA is designed to intervene on targets, which may increase the mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. Objective: This study aims to describe the protocol for a pilot randomized controlled trial designed to refine recruitment and retention strategies, document intervention fidelity and implementation outcomes, and assess changes in health beliefs and knowledge, emotional or informational support, and parent-adolescent communication quality in adolescents and their parents. Methods: Adolescents identified with symptoms of depression or anxiety, for which a health care provider recommends treatment, and their parents will be recruited from clinics where adolescents are seen for primary care. Adolescent-parent dyads will be randomized at 1:1 to both receive the SOVA websites and enhanced usual care or enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by Web-based self-report surveys and electronic health record review. The main pilot outcome is the 6-week study retention rate. Analyses will also assess changes in health beliefs and knowledge, emotional support, and parent-adolescent communication in both adolescents and their parents. Results: The project was funded in 2017. Recruitment commenced in April 2018 and enrollment is ongoing, with completion anticipated at the end of 2019 with subsequent plans for data analysis and publication submission in early 2020. Conclusions: The findings of this research will inform the design of a multisite hybrid effectiveness-implementation randomized controlled trial examining the effectiveness and optimal implementation strategies for using SOVA in community primary care settings. Trial Registration: ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 International Registered Report Identifier (IRRID): PRR1-10.2196/12117

  • JMIR Res Protoc 2019;8(1):e12117

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  RCTs - Protocols/Proposals (funded,...

  Jan 23, 2019

  Collecting Symptoms and Sensor Data With Consumer Smartwatches (the Knee OsteoArthritis, Linking Activity and Pain Study): Protocol for a Longitudinal,...

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  Authors List:

  • Anna L Beukenhorst  
  • Matthew J Parkes  
  • Louise Cook  
  • Rebecca Barnard  
  • Sabine N van der Veer  
  • Max A Little  
  • Kelly Howells  
  • Caroline Sanders  
  • Jamie C Sergeant  
  • Terence W O'Neill  
  • John McBeth  
  • William G Dixon  

  Abstract:

  Background: The Knee OsteoArthritis, Linking Activity and Pain (KOALAP) study is the first to test the feasibility of using consumer-grade cellular smartwatches for health care research. Objective: The overall aim was to investigate the feasibility of using consumer-grade cellular smartwatches as a novel tool to capture data on pain (multiple times a day) and physical activity (continuously) in patients with knee osteoarthritis. Additionally, KOALAP aimed to investigate smartwatch sensor data quality and assess whether engagement, acceptability, and user experience are sufficient for future large-scale observational and interventional studies. Methods: A total of 26 participants with self-diagnosed knee osteoarthritis were recruited in September 2017. All participants were aged 50 years or over and either lived in or were willing to travel to the Greater Manchester area. Participants received a smartwatch (Huawei Watch 2) with a bespoke app that collected patient-reported outcomes via questionnaires and continuous watch sensor data. All data were collected daily for 90 days. Additional data were collected through interviews (at baseline and follow-up) and baseline and end-of-study questionnaires. This study underwent full review by the University of Manchester Research Ethics Committee (#0165) and University Information Governance (#IGRR000060). For qualitative data analysis, a system-level security policy was developed in collaboration with the University Information Governance Office. Additionally, the project underwent an internal review process at Google, including separate reviews of accessibility, product engineering, privacy, security, legal, and protection regulation compliance. Results: Participants were recruited in September 2017. Data collection via the watches was completed in January 2018. Collection of qualitative data through patient interviews is still ongoing. Data analysis will commence when all data are collected; results are expected in 2019. Conclusions: KOALAP is the first health study to use consumer cellular smartwatches to collect self-reported symptoms alongside sensor data for musculoskeletal disorders. The results of this study will be used to inform the design of future mobile health studies. Results for feasibility and participant motivations will inform future researchers whether or under which conditions cellular smartwatches are a useful tool to collect patient-reported outcomes alongside passively measured patient behavior. The exploration of associations between self-reported symptoms at different moments will contribute to our understanding of whether it may be valuable to collect symptom data more frequently. Sensor data–quality measurements will indicate whether cellular smartwatch usage is feasible for obtaining sensor data. Methods for data-quality assessment and data-processing methods may be reusable, although generalizability to other clinical areas should be further investigated. International Registered Report Identifier (IRRID): DERR1-10.2196/10238

  • JMIR Res Protoc 2019;8(1):e10238

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  Non-Randomized Study Protocols and...

  Jan 21, 2019

  Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study

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  Authors List:

  • Allison L Naleway  
  • Sarah Ball  
  • Jeffrey C Kwong  
  • Brandy E Wyant  
  • Mark A Katz  
  • Annette K Regan  
  • Margaret L Russell  
  • Nicola P Klein  
  • Hannah Chung  
  • Kimberley A Simmonds  
  • Eduardo Azziz-Baumgartner  
  • Becca S Feldman  
  • Avram Levy  
  • Deshayne B Fell  
  • Steven J Drews  
  • Shikha Garg  
  • Paul Effler  
  • Noam Barda  
  • Stephanie A Irving  
  • Patricia Shifflett  
  • Michael L Jackson  
  • Mark G Thompson  

  Abstract:

  Background: Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges. Objective: The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention; Abt Associates; and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include (1) describing the incidence, clinical course, and severity of influenza-associated ARFI hospitalization during pregnancy; (2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza with those who were not tested; (3) describing influenza vaccination coverage in pregnant women; and (4) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization versus other noninfluenza ARFI hospitalizations. Methods: For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged from 18 to 50 years whose pregnancies overlapped with local influenza seasons from 2010 to 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction. Results: We identified approximately 2 million women whose pregnancies overlapped with influenza seasons; 550,344 had at least one hospitalization during this time. After restricting to women who were hospitalized for ARFI and tested for influenza, the IVE analytic sample included 1005 women. Conclusions: In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international partnerships created for these analyses may be useful and informative for future influenza studies. International Registered Report Identifier (IRRID): DERR1-10.2196/11333

  • JMIR Res Protoc 2019;8(1):e11333

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  Research Participants Recruitment and...

  Jan 21, 2019

  Accelerating Research With Technology: Rapid Recruitment for a Large-Scale Web-Based Sleep Study

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  Authors List:

  • Sean Deering  
  • Madeline M Grade  
  • Jaspreet K Uppal  
  • Luca Foschini  
  • Jessie L Juusola  
  • Adam M Amdur  
  • Carl J Stepnowsky  

  Abstract:

  Background: Participant recruitment can be a significant bottleneck in carrying out research studies. Connected health and mobile health platforms allow for the development of Web-based studies that can offer improvement in this domain. Sleep is of vital importance to the mental and physical health of all individuals, yet is understudied on a large scale or beyond the focus of sleep disorders. For this reason and owing to the availability of digital sleep tracking tools, sleep is well suited to being studied in a Web-based environment. Objective: The aim of this study was to investigate a method for speeding up the recruitment process and maximizing participant engagement using a novel approach, the Achievement Studies platform (Evidation Health, Inc, San Mateo, CA, USA), while carrying out a study that examined the relationship between participant sleep and daytime function. Methods: Participants could access the Web-based study platform at any time from any computer or Web-enabled device to complete study procedures and track study progress. Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic informed consent process to enroll in the study and were subsequently invited to complete an electronic baseline questionnaire. Then, they were asked to connect a wearable device account through their study dashboard, which shared their device data with the research team. The data were used to provide objective sleep and activity metrics for the study. Participants who completed the baseline questionnaires were subsequently sent a daily single-item Sleepiness Checker activity for 7 consecutive days at baseline and every 3 months thereafter for 1 year. Results: Overall, 1156 participants enrolled in the study within a 5-day recruitment window. In the 1st hour, the enrollment rate was 6.6 participants per minute (394 per hour). In the first 24 hours, the enrollment rate was 0.8 participants per minute (47 participants per hour). Overall, 1132 participants completed the baseline questionnaires (1132/1156, 97.9%) and 1047 participants completed the initial Sleepiness Checker activity (1047/1156, 90.6%). Furthermore, 1000 participants provided activity-specific wearable data (1000/1156, 86.5%) and 982 provided sleep-specific wearable data (982/1156, 84.9%). Conclusions: The Achievement Studies platform allowed for rapid recruitment and high study engagement (survey completion and device data sharing). This approach to carrying out research appears promising. However, conducting research in this way requires that participants have internet access and own and use a wearable device. As such, our sample may not be representative of the general population.

  • JMIR Res Protoc 2019;8(1):e10974

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  Theme Issue (2018): Adolescent...

  Jan 21, 2019

  Strategies to Treat and Prevent HIV in the United States for Adolescents and Young Adults: Protocol for a Mixed-Methods Study

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  Authors List:

  • Mary Jane Rotheram  
  • Maria Isabel Fernandez  
  • Sung-Jae Lee  
  • Sue Ellen Abdalian  
  • Leslie Kozina  
  • Maryann Koussa  
  • Warren Scott Comulada  
  • Jeffrey D Klausner  
  • Elizabeth Mayfield Arnold  
  • Manuel A Ocasio  
  • Dallas Swendeman  
  • Adolescent Medicine Trials Network (ATN) CARES Team

  Abstract:

  Background: Over 20% of HIV diagnoses in the United States are among youth aged 12-24 years. Furthermore, youth have the lowest rates of uptake and adherence to antiretroviral (ARV) medications and are least aware of their HIV status. Objective: Our objective was to design a set of interrelated studies to promote completion of each step of the HIV Prevention Continuum by uninfected youth at high risk (YHR), as well as completion of steps in the Treatment Continuum by youth living with HIV (YLH). Methods: Gay, bisexual, and transgender youth; homeless youth; substance-abusing youth; youth with criminal justice contact; and youth with significant mental health challenges, particularly black and Latino individuals, are being recruited from 13 community-based organizations, clinics, drop-in centers, and shelters in Los Angeles and New Orleans. Youth are screened on the basis of self-reports and rapid diagnostic tests for HIV, drug use, and sexually transmitted infections and, then, triaged into one of 3 studies: (1) an observational cohort of YLH who have never received ARV medications and are then treated—half initially are in the acute infection period (n=36) and half with established HIV infection (n=36); (2) a randomized controlled trial (RCT) for YLH (N=220); and (3) an RCT for YHR (N=1340). Each study contrasts efficacy and costs of 3 interventions: an automated messaging and weekly monitoring program delivered via text messages (short message service, SMS); a peer support intervention delivered via social media forums; and coaching, delivered via text message (SMS), phone, and in-person or telehealth contacts. The primary outcomes are assessing youths’ uptake and retention of and adherence to the HIV Prevention or Treatment Continua. Repeat assessments are conducted every 4 months over 24 months to engage and retain youth and to monitor their status. Results: The project is funded from September 2016 through May 2021. Recruitment began in May 2017 and is expected to be completed by June 2019. We expect to submit the first results for publication by fall 2019. Conclusions: Using similar, flexible, and adaptable intervention approaches for YLH and YHR, this set of studies may provide a roadmap for communities to broadly address HIV risk among youth. We will evaluate whether the interventions are cost-efficient strategies that can be leveraged to help youth adhere to the actions in the HIV Prevention and Treatment Continua. International Registered Report Identifier (IRRID): DERR1-10.2196/10759

  • JMIR Res Protoc 2019;8(1):e10759

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  Systematic Review Protocols

  Jan 18, 2019

  The Integration of Interlinkages Between Nature and Human Health in Primary Health Care: Protocol for a Scoping Review

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  Authors List:

  • Laura Lauwers  
  • Hilde Bastiaens  
  • Roy Remmen  
  • Hans Keune  

  Abstract:

  Background: International overview reports and the majority of scientific publications on interlinkages between nature and human health (NHI) do not seem to focus on the role of the health care sector. Primary health care (PHC) is often the first point of contact people have with the health care system and provides comprehensive, accessible, and community-based care that meets the health needs of individuals throughout their life. PHC is a vital backbone for linking knowledge and practice within the organization of health care. This scoping review aims to focus on the potential role of PHC in relation to NHI. Objective: The objective of this protocol is to present the method used to scope international overview reports and scientific publications on what is mentioned on the integration of NHI in PHC. Methods: The international overview reports have been screened for keywords relating to PHC. We developed a specific search strategy to scope scientific literature on NHI in relation to PHC. The scientific literature search ran in Web of Science (WOS) and PubMed from inception to May 2017. The scientific publications are screened by 2 independent reviewers, which will result in a list of relevant publications that meet eligibility and inclusion criteria. Results: On the basis of a first screen on the title of the first 200 results in both search engines, we decided to restrict to WOS. First insights in the international overview reports and the quantitative overview of the results in WOS give a first impression of a missing link between NHI and PHC. The findings are expected to identify knowledge gaps in the translation of evidence on NHI in PHC practices and the role of PHC regarding the application of that evidence in health care practice. Conclusions: This is, to our knowledge, the first study that seeks to relate existing knowledge on NHI to PHC. The presentation of our method through this protocol allows researchers to build upon and improve our work in future research on the practical implementation of NIH. The findings of the scoping review are expected to guide future scientific research, international policy directives, and PHC workers to fill the gaps in the integration of NHI in PHC. International Registered Report Identifier (IRRID): DERR1-10.2196/12510

  • JMIR Res Protoc 2019;8(1):e12510

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  Formative Studies and Development...

  Jan 18, 2019

  Primary Prevention of Intimate Partner Violence Among Recently Married Dyads Residing in the Slums of Pune, India: Development and Rationale for a Dyadic...

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  Authors List:

  • Ameeta Shivdas Kalokhe  
  • Sandhya Iyer  
  • Tuman Katendra  
  • Keshav Gadhe  
  • Ambika R Kolhe  
  • Anuradha Paranjape  
  • Carlos del Rio  
  • Rob Stephenson  
  • Seema Sahay  

  Abstract:

  Background: Intimate partner violence (IPV) is frequently experienced by women of low socioeconomic status in India. It is a human rights violation and associated with negative effects on physical and mental well-being, underscoring the need for effective prevention strategies. Objective: This study aimed to develop a dyadic intervention for the primary prevention of IPV among newly married couples residing in slum communities in India. Methods: The intervention was developed using a community-based, mixed-methods design rooted in couple-interdependence theory and guided by the intervention mapping (IM) framework. It used the six critical IM steps to inform the content and delivery of the intervention: (1) needs assessment, (2) preparation of matrices of change objectives, (3) selection of theory-based methods and practical applications, (4) production of intervention components and materials, (5) intervention adoption and implementation, and (6) evaluation planning. Results: The resulting Ghya Bharari Ekatra (Take a Flight Together) intervention is intended to be delivered in 6 weekly sessions by a trained pair of male and female lay community educators to groups of 3 to 5 newly married couples in the community in which they reside. It uses games, discussions, self-reflections, and skill-building exercises to cover the following topics: enhancing relationship quality time, self-esteem and resilience, communication and conflict management, goal setting and implementation, sexual communication and sexual health and reproductive health knowledge, and redefining and challenging norms surrounding IPV occurrence. The formative work guided the protocol, including module duration and timing (2-hour sessions of convenience to participants), ordering of modules (based on potential level of interest and sensitivity of the topics), content (ie, informed scripts of role plays and films), intervention delivery methods (ie, interactive activities), and selection of the interventionists (based on capacity to connect with participants) and venue (community-based, convenient, and safe spaces). Ghya Bharari Ekatra was piloted between January and May 2018, and evaluation is presently underway. Conclusions: Ghya Bharari Ekatra is evidence-based, grounded in intervention-mapping, and developed and iteratively refined using a community-based participatory research approach, suggesting it has great potential to be an acceptable and effective solution to preventing IPV among newly married couples. Trial Registration: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134

  • JMIR Res Protoc 2019;8(1):e11533

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  RCTs - Protocols/Proposals (non-eHealth)

  Jan 17, 2019

  TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic...

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  Authors List:

  • Nikhil Chauhan  
  • Mary F Mulcahy  
  • Riad Salem  
  • Al B Benson III  
  • Eveline Boucher  
  • Janet Bukovcan  
  • David Cosgrove  
  • Chantal Laframboise  
  • Robert J Lewandowski  
  • Fayaz Master  
  • Bassel El-Rayes  
  • Jonathan R Strosberg  
  • Daniel Y Sze  
  • Ricky A Sharma  

  Abstract:

  Background: Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. Objective: The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. Methods: EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy with either an oxaliplatin-based or irinotecan-based regimen and are eligible for second-line chemotherapy with the alternate regimen. Patients were randomized 1:1 to the TARE group (chemotherapy with TARE in place of the second chemotherapy infusion and subsequent resumption of chemotherapy) or the control group (chemotherapy alone). The addition of targeted agents is permitted. The primary end points are progression-free survival and hepatic progression-free survival. The study objective will be considered achieved if at least one primary end point is statistically significant. Secondary end points are overall survival, time to symptomatic progression defined as Eastern Cooperative Oncology Group Performance Status score of 2 or higher, objective response rate, disease control rate, quality-of-life assessment by the Functional Assessment of Cancer Therapy-Colorectal Cancer questionnaire, and adverse events. The study is an adaptive trial, comprising a group sequential design with 2 interim analyses with a planned maximum of 420 patients. The study is designed to detect a 2.5-month increase in median progression-free survival, from 6 months in the control group to 8.5 months in the TARE group (hazard ratio [HR] 0.71), and a 3.5-month increase in median hepatic progression-free survival time, from 6.5 months in the control group to 10 months in the TARE group (HR 0.65). On the basis of simulations, the power to detect the target difference in either progression-free survival or hepatic progression-free survival is >90%, and the power to detect the target difference in each end point alone is >80%. Results: Patient enrollment ended in October 2018. The first interim analysis in June 2018 resulted in continuation of the study without any changes. Conclusions: The EPOCH study may contribute toward the establishment of the role of combination therapy with TARE and oxaliplatin- or irinotecan-based chemotherapy in the second-line treatment of mCRC of the liver. Trial Registration: ClinicalTrials.gov NCT01483027; https://clinicaltrials.gov/ct2/show/NCT01483027 (Archived by WebCite at http://www.webcitation.org/734A6PAYW) International Registered Report Identifier (IRRID): RR1-10.2196/11545

  • JMIR Res Protoc 2019;8(1):e11545

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  RCTs - Protocols/Proposals (eHealth)

  Jan 17, 2019

  A Web-Based Recovery Program (ICUTogether) for Intensive Care Survivors: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Beverley Ewens  
  • Helen Myers  
  • Lisa Whitehead  
  • Karla Seaman  
  • Deborah Sundin  
  • Joyce Hendricks  

  Abstract:

  Background: Those who experience a critical illness or condition requiring admission to an intensive care unit (ICU) frequently experience physical and psychological complications as a direct result of their critical illness or condition and ICU experience. Complications, if left untreated, can affect the quality of life of survivors and impact health care resources. Explorations of potential interventions to reduce the negative impact of an ICU experience have failed to establish an evidence-based intervention. Objective: The aim of this study is to evaluate the impact of a Web-based intensive care recovery program on the mental well-being of intensive care survivors and to determine if it is a cost-effective approach. Methods: In total, 162 patients that survived an ICU experience will be recruited and randomized into 1 of 2 groups. The intervention group will receive access to the Web-based intensive care recovery program, ICUTogether, 2 weeks after discharge (n=81), and the control group will receive usual care (n=81). Mental well-being will be measured using the Hospital Anxiety and Depression Scale, The Impact of Events Scale-Revised and the 5-level 5-dimension EuroQoL at 3 time points (2 weeks, 6 months, and 12 months post discharge). Family support will be measured using the Multidimensional Scale of Perceived Social Support at 3 time points. Analysis will be conducted on an intention-to-treat basis using regression modeling. Covariates will include baseline outcome measures, study allocation (intervention or control), age, gender, length of ICU stay, APACHE III score, level of family support, and hospital readmissions. Participants’ evaluation of the mobile website will be sought at 12 months postdischarge. A cost utility analysis conducted at 12 months from a societal perspective will consider costs incurred by individuals as well as health care providers. Results: Participant recruitment is currently underway. Recruitment is anticipated to be completed by December 2020. Conclusions: This study will evaluate a novel intervention in a group of ICU survivors. The findings from this study will inform a larger study and wider debate about an appropriate intervention in this population.

  • JMIR Res Protoc 2019;8(1):e10935

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  RCTs - Protocols/Proposals (funded,...

  Jan 16, 2019

  Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a...

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  Authors List:

  • Alyssa CP Sawyer  
  • Amy L Kaim  
  • Christy E Reece  
  • Denise McDonald  
  • Huynh-Nhu Le  
  • Jennifer Clark  
  • John W Lynch  
  • Michael G Sawyer  

  Abstract:

  Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. Objective: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. Methods: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. Results: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. Conclusions: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. International Registered Report Identifier (IRRID): RR1-10.2196/11549

  • JMIR Res Protoc 2019;8(1):e11549

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  Non-Randomized Studies (funded,...

  Jan 16, 2019

  Human Papillomavirus Infection and Transmission Among Couples Through Heterosexual Activity (HITCH) Cohort Study: Protocol Describing Design, Methods, and...

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  Authors List:

  • Mariam El-Zein  
  • François Coutlée  
  • Pierre-Paul Tellier  
  • Michel Roger  
  • Eduardo L Franco  
  • Ann N Burchell  
  • HITCH Study Group

  Abstract:

  Background: Human papillomavirus (HPV) epidemiological research has generally been individual based, typically focusing on women, with couple-based research mostly consisting of cross-sectional assessment of prevalent HPV infection in both partners. Objective: The HPV Infection and Transmission among Couples through Heterosexual activity (HITCH) study was set up to investigate the transmissibility of HPV among young, recently formed couples in Montreal, Canada. This paper provides an overview of the HITCH cohort study design and procedures as well as a narrative summary of the most important findings. Methods: HITCH is a longitudinal investigation of HPV transmission in recently formed heterosexual partnerships initiated within 6-month pre-enrollment, a time at which considerable transmission is believed to occur. A total of 549 newly formed dyads were recruited (2005-2011) from postsecondary institutions, including 502 young women and their male partners. An additional 46 males were enrolled at follow-up, as some women enrolled a subsequent partner at follow-up. Women aged 18-24 years were followed for 24 months for acquisition of HPV types not present at enrollment, whereas men returned for a single follow-up visit at month 4, for a sum total of 3361 clinic visits. The last follow-up visit occurred in January 2014. Extensive sociodemographic, sexual behavioral, and medical history data were collected every 2-4 months using computer-assisted, self-administered questionnaires. Furthermore, participants provided genital, blood, oral, and hand specimens for HPV assessment. Results: Although in its early analysis stage, HITCH has produced important publications. Findings from HITCH have increased the available knowledge about the natural history of HPV transmission and its determinants, provided further evidence regarding oral-oral and oral-genital routes of HPV transmission, and supplied empirically valid epidemiological parameters of HPV transmission to assist mathematical modelers in health economic assessments. In addition, HITCH data were made available to several multistudy collaborations evaluating new HPV detection assays and evidence for-or-against HPV type replacement following the introduction of HPV vaccination. Conclusions: HITCH will continue to offer a unique resource for research on HPV transmission. International Registered Report Identifier (IRRID): RR1-10.2196/11284

  • JMIR Res Protoc 2019;8(1):e11284

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  RCTs - Protocols/Proposals (funded,...

  Jan 16, 2019

  Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Manuel Herrera-Usagre  
  • Vicente Santana  
  • Ramon Burgos-Pol  
  • Juan Pedro Oliva  
  • Eliazar Sabater  
  • Maria Rita-Acosta  
  • Miguel Angel Casado  
  • Susana Cruces  
  • Manuel Pacheco  
  • Carlos Solorzano Perez  

  Abstract:

  Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems to patients and professionals. In Spain, no current evidence is available on either the rate of compliance or the impact of good compliance with preoperative recommendations by patients in the ambulatory setting. However, it is known that around 25% of surgical cancellations in the major ambulatory surgery (MAS) are due to poor compliance with these recommendations and, therefore, avoidable. Introducing innovative tools based on mobile health (mHealth) apps may help patients meet the preoperative recommendations and, consequently, reduce the rate of cancellations in the ambulatory setting. Objective: The objective of this study was to evaluate the effectiveness of the Listeo+ mHealth app as a tool for improving compliance with preoperative recommendations in MAS versus standard of care (SOC). Methods: A multicenter, randomized, open-label clinical trial that compares SOC with the additional use of Listeo+, a specific mHealth app for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, while those in the intervention group will additionally use the Listeo+ mHealth app. There will be a competitive recruitment of 790 patients during 6 months in 4 hospitals in Andalusia (Spain) that belong to the National Health System. The primary efficacy outcome is the level of compliance with preoperative recommendations. Secondary outcomes include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Simple randomization 1:1 procedure will be used to allocate patients to each study group. Results: The technological development of Listeo+ and the integration and interoperability of information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the 4 participating centers. After an intermediate analysis performed 10 months after the start of the recruitment phase, the data collection and cleaning phases are estimated to be completed in April 2019, and the analysis with the final results will be conducted in July 2019. Conclusions: Progress in the integration and interoperability of information systems represents a major step forward in the field of mHealth. The app will allow health professionals to monitor in real-time patients’ preparation and critical preoperative recommendations fulfillment. We expect a reduction in avoidable preoperative cancellations due to a lack of or a poor patient preparation. Self-assessed Web-based questionnaires and focus group will provide important information about the perceived usability and utility of Listeo+ app among patients and health care professionals. International Registered Report Identifier (IRRID): DERR1-10.2196/10938

  • JMIR Res Protoc 2019;8(1):e10938

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