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JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results


Journal Description


JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)

JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)


Recent Articles:

  • Men in group therapy. Source: Image created by the Authors; Copyright: Etheldreda Nakimuli-Mpungu; URL:; License: Creative Commons Attribution (CC-BY).

    The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a...


    Background: There is limited information on the effectiveness of task shifting of mental health services in populations with HIV. Objective: This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care. Methods: Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression. Treated PLWH will be evaluated at baseline, after the end of treatment, and at 6-month intervals thereafter for 2 years. Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment. Secondary outcomes will include measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data. Primary and secondary outcomes as well as subgroup analyses will be conducted at the individual level using multilevel random effects regression analyses adjusting for clustering in health centers. A process evaluation using mixed methods to assess acceptability, feasibility, fidelity, causal mediating processes, and contextual influences in the trial will be conducted. Results: The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, the AIDS Support Organization, and the Uganda National Council of Science and Technology. A data and safety monitoring board has been put in place to monitor trial progress. A total of 1140 persons living with HIV have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies. Conclusions: This cluster randomized trial will provide critical evidence to support culturally sensitive group-based psychotherapy for depression treatment in sub-Saharan Africa. Process evaluation outcomes will provide contextual information that health care and public health stakeholders can use to guide implementation decisions for their particular setting. Trial Registration: Pan African Clinical Trials Registry (PACTR): 201608001738234; appmanager/atm/atmregistry?dar=true&tNo=PACTR201608001738234 (Archived by WebCite at 6vUAgAQlj)

  • Source: The Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    MyVoice National Text Message Survey of Youth Aged 14 to 24 Years: Study Protocol


    Background: There has been little progress in adolescent health outcomes in recent decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Objective: Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real time to leverage youth perspectives to impact policy. Methods: Youth aged 14 to 24 years are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers, and policy makers to inform salient policies. A youth-centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required because the survey is of minimal risk to participants. Recruitment occurs online (eg, Facebook, Instagram, university health research website) and in person at community events. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. Results: We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. Conclusions: MyVoice quickly ascertains the thoughts and opinions of youth in real time using a widespread, readily available technology—text messaging. Results are disseminated to researchers, policy makers, and youth-serving organizations through a variety of methods. Policy makers and organizations also share their priority areas with the research team to develop additional question sets to inform important policy decisions. Youth-serving organizations can use results to make decisions to promote youth well-being.

  • Source: Flickr; Copyright: ThoroughlyReviewed; URL:; License: Creative Commons Attribution (CC-BY).

    Clinic Versus Online Social Network–Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial


    Background: Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. Objective: This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. Methods: Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Results: The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. Conclusions: Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. Trial Registration: NCT02646618; (Archived by WebCite at

  • iPad showing the Stay Strong app. Source: Image created by the Authors; Copyright: Amelia Gulliver; URL:; License: Creative Commons Attribution (CC-BY).

    A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial


    Background: There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. Objective: This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. Methods: The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. Results: The program will be delivered over a period of approximately 4 months, commencing June 2017. Conclusions: If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers.

  • Source: Obesity Action Coalition; Copyright: Obesity Action Coalition; URL:; License: Fair use/fair dealings.

    The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics


    Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

  • Source: Wikimedia Commons; Copyright: Erica Mater (US Navy); URL:,_Capt._David_Thompson_performs_an_ear_tube_surgery_on_a_young_hospital_patient.jpg; License: Public Domain (CC0).

    The Second-Look Procedure for Transoral Videolaryngoscopic Surgery for T1 and T2 Laryngeal, Oropharyngeal, and Hypopharyngeal Cancer Patients: Protocol for a...


    Background: Transoral videolaryngoscopic surgery (TOVS) has been widely applied for early T stage head and neck cancer. The resection is performed with a minimum safety margin for function preservation under a limited surgical field of view, making it difficult to be certain of complete resection. Objective: Our aim is the evaluation of the completeness of resection by initial TOVS resection, and the possibility of primary control by TOVS alone, allowing for repeat procedures for function preserving treatment in early T stage laryngeal, oropharyngeal, and hypopharyngeal cancer patients. Methods: Patients are treated by TOVS for the primary site with or without neck dissection. Patients are divided in two groups based on the results of the pathological evaluation of the surgical specimen; the control group in which the resection is considered to be complete, and the intervention (second-look procedure) group in which incomplete tumor resection is suspected. The predictive factors for the possibility of complete resection by TOVS will then be analyzed. Results: Patient enrollment started on January 1, 2014, and closed on March 31, 2016, with 54 patients. The control group consists of 27 patients, the intervention group is 21 patients, and 6 patients were excluded. There were no clinical differences between the control and intervention groups. The observation period will end on December 31, 2018. Conclusions: TOVS has potential for both definitive resection and function preservation with minimal invasiveness. Identifying the limitations of TOVS is beneficial to ensure accurate treatment selection in early T stage head and neck cancer patients. Trial Registration: UMIN Clinical Trials Registry: UMIN000012485; recptno=R000014472 (Archived by WebCite at

  • Source: Flickr; Copyright: Direct Relief; URL:; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Development of an Index of Engagement in HIV Care: An Adapted Internet-Based Delphi Process


    Background: Improving engagement in medical care among persons living with human immunodeficiency virus (HIV) is critical to optimizing clinical outcomes and reducing onward transmission of HIV. However, a clear conceptualization of what it means to be engaged in HIV care is lacking, and thus efforts to measure and enhance engagement in care are limited. Objective: This paper describes the use of a modified online Delphi process of consensus building to solicit input from a range of HIV and non-HIV researchers and providers, and to integrate that input with focus group data conducted with HIV-infected patients. The overarching goal was to generate items for a patient-centered measure of engagement in HIV care for use in future research and clinical practice. Methods: We recruited 66 expert panelists from around the United States. Starting with six open-ended questions, we used four rounds of online Delphi data collection in tandem with 12 in-person focus groups with patients and cognitive interviews with 25 patients. Results: We recruited 66 expert panelists from around the United States and 64 (97%) were retained for four rounds of data collection. Starting with six open-ended questions, we used four rounds of online Delphi data collection in tandem with 12 in-person focus groups with patients and cognitive interviews with 25 patients. The process resulted in an expansion to 120 topics that were subsequently reduced to 13 candidate items for the planned assessment measure. Conclusions: The process was an efficient method of soliciting input from geographically separated and busy experts across a range of disciplines and professional roles with the aim of arriving at a coherent definition of engagement in HIV care and a manageable set of survey items to assess it. Next steps are to validate the utility of the new measure in predicting retention in care, adherence to treatment, and clinical outcomes among patients living with HIV.

  • Source: Image created by the Authors; Copyright: Thuy Mai Luu and Perrine Peckre; URL:; License: Creative Commons Attribution (CC-BY).

    Web-Based Intervention to Teach Developmentally Supportive Care to Parents of Preterm Infants: Feasibility and Acceptability Study


    Background: Preterm birth affects 8% to 11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positive impact on early motor and cognitive development and on parental well-being. However, these programs are often difficult to implement in a real-life setting due to lack of resources. Hence, our multidisciplinary team developed Mieux Agir au Quotidien (MAQ) to teach developmentally supportive care to parents of preterm infants with the goal of improving child development and parental outcomes. Our intervention included 3 in-person workshops that occurred prior to hospital discharge and a Web-based platform with written and videotaped materials that addressed 5 main themes: (1) infant behavioral cues, (2) flexion positioning; (3) oral feeding support, (4) parent-infant interactions, and (5) anticipation of developmental milestones. Objective: This study aimed to test the feasibility and acceptability of the intervention by parents of preterm infants and assess clinical benefits on child neurodevelopment and parental outcomes during the first year of life. Methods: A total of 107 infants born at <30 weeks and admitted to Sainte-Justine Hospital neonatal intensive care unit and their parents were enrolled in a nonrandomized controlled before-and-after interventional study (intervention n=55, comparison n=52). Acceptability of the program was assessed with a user satisfaction questionnaire. When the infants were at 4 months’ corrected age, all parents completed questionnaires on infant temperament, parenting stress, sense of competence, and parenting satisfaction. At 12 months’ corrected age, neurodevelopmental testing was performed on infants using the Alberta Infant Motor Scale and the Bayley Scales of Infant and Toddler Development, Third Edition. Comparisons between the 2 groups were done using independent t tests, Wilcoxon rank-sum tests, and Fisher exact tests. Results: The majority of parents (43/45) were satisfied with the intervention program and all would recommend MAQ to others. MAQ met their need for evidence-based information that proved useful to support their child development. No difference in parental or child neurodevelopmental outcomes was detected in this pilot study for most outcomes except for higher median scores for parental coercive behaviors in the intervention group, although proportions scoring in the coercive range did not differ. Conclusions: Acceptability of the program was high among parents thus supporting the relevance of such intervention. A larger study using a randomized controlled trial design is needed to better document impact on parent and children and investigate how Web-based technologies can efficiently complement individualized intervention to alleviate the burden on health care resources.

  • Image from a sample online advertisement of a young person who may fit the inclusion criteria for Project Moxie. Source: Image created by Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial


    Background: Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Objective: Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. Methods: This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study’s website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Results: Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible participants. Conclusions: Combining home-based HIV testing and video-based counseling allows TY, an often stigmatized and marginalized population, to test for HIV in a safe and nonjudgmental setting of their choosing. This approach creates an opportunity to reduce the high rate of HIV among TY through engagement in care, support, and linkage to the HIV treatment cascade for those who test positive. Trial Registration: NCT03185975; (Archived by WebCite at

  • Source: Pixnio; Copyright: Amanda Mills; URL:; License: Public Domain (CC0).

    Online Self-Management Support for Family Caregivers to Help Them Manage Behavior Changes in Their Relative With Dementia: Study Protocol for a Randomized...


    Background: Online interventions are potentially effective ways to support family caregivers in the management of behavior changes in their relative with dementia. Objective: The objective of this paper is to present the design of a study evaluating and comparing 3 intervention arms for online self-management support. Methods: A randomized controlled trial (RCT) will be conducted with a total of 81 family caregivers of community-dwelling people with dementia in the Netherlands. Family caregivers will be randomly allocated to one of the following intervention arms: (1) a major self-management support intervention consisting of personal email contacts with a nurse specialized in dementia care, online videos, and electronic bulletins (e-bulletins); (2) a medium self-management support intervention consisting of only online videos and e-bulletins; and (3) a minor self-management support intervention with only e-bulletins. The primary outcome is the self-efficacy of the family caregiver. The secondary outcomes are the behavior problems of the person with dementia as reported by the family caregiver, and positive and negative aspects of the relationship. Background characteristics (eg, type of family relationship) will also be assessed. All data for the RCT will be collected via online questionnaires, administered before the intervention (T0), after 6 weeks (T1), and after 12 weeks (T2). Alongside the RCT, a process evaluation will be conducted, based on a number of evaluation questions and semi-open interviews with family caregivers. Results: Data collection will be completed in August 2017. Study results will be reported in early 2018. Conclusions: The study will shed more light on the effect of online self-management support interventions and insights will be gained into whether a major intervention, consisting of personal email contacts with specialized nurses, videos, and e-bulletins, has more effect than smaller online interventions. This is relevant in an age with increasing numbers of people with dementia, growing pressure on family caregivers, more and more people using the Internet, and increasing healthcare costs. Trial Registration: Nederlands Trial Registry (NTR): NTR6237; (Archived by WebCite at

  • Picture of couple from the study. Source: Image created by the Authors; Copyright: The Authors; URL: URL:; License: Creative Commons Attribution (CC-BY).

    Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study


    Background: Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective: The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods: This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results: In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions: This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial. Trial Registration: NCT02265757; NCT02265757 (Archived by WebCite at

  • Source: Pixabay; Copyright: StockSnap; URL:; License: Public Domain (CC0).

    In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial


    Background: Eight-week mindfulness-based interventions (MBIs) have a beneficial impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who do not have in-person MBIs available in their communities. Objective: This paper outlines the rationale, development, and design of a randomized controlled trial comparing the effects of an MBI delivered in person or via eHealth in adolescents with a chronic illness. Quantitative outcomes will include mindfulness skills acquisition (primary outcome), effects of the MBI on self-reported mood, anxiety, self-esteem, illness perception, and physiological stress (via salivary cortisol), and qualitative outcomes will include individual practice, participant appreciation, and adaptation of the MBI for eHealth. Methods: This is a randomized noninferiority mixed methods study comparing 2 MBI arms: in-person and eHealth. Participants are eligible to participate if they are aged 13 to 18 years, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study, and are currently followed by a health care provider. Each participant will receive an adapted 8-week MBI delivered either in person at a tertiary pediatric hospital or via a secure audio-visual platform allowing group interactions in real time. Groups will be facilitated by 2 experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform and through semistructured interviews, participant log books, facilitator log books, and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. Results: Data collection is currently underway. Data analysis, manuscript writing, and additional publications are expected to be completed in the winter and spring of 2018. Conclusions: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception, and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of 8-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. Trial Registration: NCT03067207; (archived by WebCite at

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  • MISSION Severe Asthma: Modern Innovative Solutions to Improve Outcomes in Severe Asthma. A mixed methods observational comparison of clinical outcomes in MISSION versus current care delivery.

    Date Submitted: Dec 11, 2017

    Open Peer Review Period: Dec 11, 2017 - Dec 25, 2017

    The Specialised Services Pathway for Severe Asthma (NHS Commissioning Board, 2012/2013) recognises the burden of uncontrolled disease, ordinarily amenable to anti-inflammatory medications and the prog...

    The Specialised Services Pathway for Severe Asthma (NHS Commissioning Board, 2012/2013) recognises the burden of uncontrolled disease, ordinarily amenable to anti-inflammatory medications and the progression to longer term ‘severe’ disease necessitating high-cost therapies (e.g. Bronchial Thermoplasty). The identification and appropriate referral to a specialist asthma service is often delayed by several months or years due to poor recognition and understanding of symptom severity. Current severe asthma services may take several months to provide a comprehensive multi-disciplinary assessment often necessitating multiple hospital visits and costing up to £5000 per patient. MISSION – Modern Innovative Solutions to Improve Outcomes in Severe Asthma is a novel service model pilot developed by asthma specialists from Portsmouth and Southampton asthma services. MISSION Severe Asthma identified patients with poorly controlled disease from General Practice (GP) databases who had not been under secondary outpatient care in the last 12 months or who were not known to secondary care. In one-or two-stop assessments, a thorough review of diagnosis, disease phenotype and control is undertaken. This Protocol outlines a mixed methods study to assess the impact on disease control, unscheduled healthcare usage and quality of life in patients seen in the MISSION clinic compared to a closely matched cohort who declined to attend.

  • Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study

    Date Submitted: Dec 8, 2017

    Open Peer Review Period: Dec 11, 2017 - Dec 25, 2017

    Background: Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioural change interventions in...

    Background: Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioural change interventions in this population. Access to web-portals and provision of activity monitors to provide feedback may support behaviour change by encouraging patient engagement in physical therapy. The web-portal evaluated in this study will provide a system to monitor physical activity and sleep, for use by both clinician and patient, along with symptom and health related quality of life tracking capabilities. Objective: To evaluate the feasibility of a web-based portal that provides activity monitoring and personalised messaging to increase physical activity in people with cancer. Methods: Using a longitudinal cohort design, people with cancer will be serially allocated to three intervention cohorts and followed for 10 weeks. Group 1 will be provided a wearable activity monitor and access to a web-based portal. Group 2 will receive the same as group 1 and in addition will receive a weekly activity summary message. Group 3 will receive the same as Group 1 and 2 and in addition will receive a personalised weekly coaching message. Feasibility of the use of the portal is the primary outcome. Results: Expected in February 2018 Conclusions: The study findings will provide information about the relative effects of eHealth initiatives to facilitate physical activity behavioural change in people with cancer.

  • A digital app to aid detection, monitoring and management of Dyslexia (DIMMAND) in young children: Project Protocol

    Date Submitted: Dec 9, 2017

    Open Peer Review Period: Dec 11, 2017 - Dec 25, 2017

    Background: Dyslexia is a lifelong problem affecting up to 1 in 10 to 20 people in the UK, and as the most common learning difficulty puts immense pressure on already over-stretched public finances. O...

    Background: Dyslexia is a lifelong problem affecting up to 1 in 10 to 20 people in the UK, and as the most common learning difficulty puts immense pressure on already over-stretched public finances. Our aim is to create a digital health solution that will radically improve dyslexia detection at an early stage and self-management. This is expected to reduce intervention costs, improve quality of life for sufferers and enable them to be more independent. Objective: We discuss the rationale and protocol for the design and development of a digital health tool aimed at improving the early detection, monitoring and management of dyslexia (DIMMAND) in young children (4 to 8 years). This will be delivered using a game-based digital app aimed at children, parents and teachers. It will firstly assess, then monitor and manage progress in a convenient, cost-effective and private environment. Methods: The proposed app will be designed and developed in two stages. In the first stage (already underway), the full functional specification of the games that constitute the app will be designed, together with the overall architecture of the app. Prototype proof-of-concept implementation for several of these games, and commercialization strategies will also be developed. The (proposed) second stage will see the design implemented into a fully-fledged app. Results: The project has commenced in March 2017. The final outcomes of the first stage will be available in March 2018. Conclusions: DIMMAND has the potential to provide significant positive healthcare and economic impact. It is expected to reduce intervention costs, improve dyslexia detection at an early stage and aid self-management.

  • Integrated models of care for people living with hepatitis C virus and a substance use disorder: A protocol for a systematic review

    Date Submitted: Nov 30, 2017

    Open Peer Review Period: Dec 7, 2017 - Dec 21, 2017

    Background: People living with a substance use disorder (SUD) are a key population within the hepatitis C virus (HCV) epidemic. While integrated and community-based models of care have shown positive...

    Background: People living with a substance use disorder (SUD) are a key population within the hepatitis C virus (HCV) epidemic. While integrated and community-based models of care have shown positive outcomes among this population, the literature has been primarily focused on the human immunodeficiency virus (HIV) context. This paper outlines a systematic review protocol on the impact of various integrated models of care, which includes HCV and SUD services, on various treatment, and health-related outcomes among this population. Objective: Determine the impact of the impact of integrated models of care on HCV and addiction treatment and health-related outcomes for adults living with HCV and a SUD. Methods: We will search a total of five databases, article reference lists, and abstracts from relevant conferences that investigate the impact of integrated models of care on treatment and health-related outcomes among people living with HCV and a SUD. Database searches will be conducted and titles, abstracts, and full-text will be independently reviewed in separate stages. The methodological quality of included quantitative research studies will be assessed using a validated tool. Data from included articles will be extracted using a standardized form and synthesized in a narrative account. Conclusions: The systematic review will describe different integrated models of care that could be effective in improving the health and well-being of people living with HCV and a SUD. Results of this review could also identify quality improvement strategies to minimize the health and cost burden imposed on patients, healthcare professionals, and the healthcare system. Systematic Review Registration: PROSPERO CRD42017078445

  • The unanticipated challenges associated with implementing an observational study protocol in a large scale physical activity and GPS data collection

    Date Submitted: Nov 30, 2017

    Open Peer Review Period: Dec 2, 2017 - Dec 16, 2017

    Large scale primary data collections are complex, costly, and time consuming. Study protocols for trial based research are now commonplace with a growing number of similar pieces of work being publis...

    Large scale primary data collections are complex, costly, and time consuming. Study protocols for trial based research are now commonplace with a growing number of similar pieces of work being published on observational research. However, a likely useful addition to the literature base are publications that describe the issues and challenges faced whilst conducting observational studies. These can provide researchers with insightful knowledge that can inform funding proposals or project development work. The SPACES (Studying Physical Activity in Children’s Environments across Scotland) study was designed to collect objectively measured physical activity and Global Positioning System (GPS) data from 10/11 year old children across Scotland, using a postal delivery method. In this paper we identify and reflectively discuss the unforeseen or often unpublished issues associated with organising and implementing a large scale objectively measured physical activity and GPS data collection. The three main phases of the project (recruitment, delivery of project materials, and data collection and processing) are described within a two stage framework: (i) intended design and (ii) implementation of the intended design. Unanticipated challenges arose that influenced the data collection process, and encompass four main impact categories: i) cost, budget and funding; ii) project timeline; iii) participation/engagement; and iv) data challenges. The main unforeseen issues that impacted our timeline included: the informed consent process for children under the age of 18; the use of, and coordination with, the postal service to deliver study information and equipment; the variability associated with when participants began the data collection and the time taken to send devices and consent forms back (1 – 12 months). Unanticipated budgetary issues included the identification of some study materials (AC power adapter) not fitting through letterboxes, and the employment of fieldworkers to increase recruitment and the return of consent forms. Finally, we encountered data issues when processing physical activity and GPS data that had been initiated across Daylight Savings Time (DST). We present learning points and recommendations that may benefit future studies of similar methodology in their early stages of development.

  • Formative evaluation as an iterative input to the development of an eHealth concept: the applicability of combining different methodologies to facilitate a rapid development framework for complex eHealth solutions

    Date Submitted: Nov 29, 2017

    Open Peer Review Period: Nov 30, 2017 - Dec 14, 2017

    Background: Implementation of eHealth in traditional health care clinics requires an understanding of the complexity of involved health care systems, organisational settings, and stakeholder groups. M...

    Background: Implementation of eHealth in traditional health care clinics requires an understanding of the complexity of involved health care systems, organisational settings, and stakeholder groups. Moreover, understanding of the underlying interplay between groups and of the software/hardware technology is essential. Objective: The aim of this paper is to describe and discuss the relevance and applicability of an iterative process guiding the development of an eHealth concept as both a technical and organizational entity, developed across different health care systems. Methods: A formative evaluation comprising the methodologies of Participatory Design, Theory-based Stakeholder Evaluation, and a series of Feasibility Studies was conducted including patients, health care professionals, and software developers. Through continuous feedback and dialogs within the project consortium, we aimed at creating mutual insight and optimizing the development of an eHealth Information and Communication Technology platform and its components. Results: Drawing on different methodologies, the formative evaluation served as a continuous and applicable input to the development process of an eHealth concept for Rheumatoid Arthritis in diverse health care settings across Europe. Input from patients and health care professionals were actively used for adjusting the visual, conceptual, and practical design of the concept. Furthermore, the continuous dialog within the consortium enabled continuous learnings and adaptions of the eHealth concept as well as the evaluation. Conclusions: A formative evaluation process including continuous involvement of stakeholder groups provides valuable information guiding the development of an eHealth concept and constitutes a basis for a subsequent implementation and evaluation.