JMIR Publications

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  Grant Proposals (funded, non-ehealth)

  Jan 17, 2020

  The Association Between Selected Molecular Biomarkers and Ambulatory Blood Pressure Patterns in African Chronic Kidney Disease and Hypertensive Patients...

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  Authors List:

  • Abiodun Moshood Adeoye  
  • Oladimeji Adebayo  
  • Busayo Abiola  
  • Bamidele Iwalokun  
  • Bamidele Tayo  
  • Fadi Charchar  
  • Akinlolu Ojo  
  • Richard Cooper  

  Abstract:

  Background: Chronic kidney disease (CKD) is a burgeoning epidemic in sub-Saharan Africa. Abnormal blood pressure variations are prevalent in CKD and potentiate the risk of cardiovascular morbidity and mortality. Certain genetic variants (angiotensin II receptor type 1 1166 A>C and angiotensin-converting enzyme insertion and deletion polymorphisms) and biomarkers such as interleukin–6, tumor necrosis factor, soluble (s) E-selectin, homocysteine, and highly sensitive C-reactive protein have been shown to affect blood pressure variability among non-African CKD, hypertensive. and nonhypertensive CKD population. However, the contributions of the pattern, genetic, and environmental determinants of ambulatory blood pressure in African CKD have not been characterized. Understanding these interactions may help to develop interventions to prevent major cardiovascular events among people with CKD. Objective: The overarching objective of this study is to identify, document, and develop approaches to address related phenomic, genetic, and environmental determinants of ambulatory blood pressure patterns in African CKD and non-CKD hypertensive patients compared with normotensive controls. Methods: This is a longitudinal short-term follow-up study of 200 adult subjects with CKD and 200 each of age-matched hypertensives without CKD and apparently healthy controls. Demographic information, detailed clinical profile, electrocardiography, echocardiography, and 24-hr ambulatory blood pressure measurements will be obtained. Blood samples will be collected to determine albumin-creatinine ratio, fasting plasma glucose, lipid profile, electrolytes, urea and creatinine, C-reactive protein, serum homocysteine, fibroblast growth factor–23, and complete blood count, while 2 mL blood aliquot will be collected in EDTA (ethylenediaminetetraacetic acid) tubes and mixed using an electronic rolling system to prevent blood clots and subsequently used for DNA extraction and genetic analysis. Results: A total of 239 participants have been recruited so far, and it is expected that the recruitment phase will be complete in June 2020. The follow-up phase will continue with data analysis and publications of results. Conclusions: This study will help stratify Nigerian CKD patients phenotypically and genotypically in terms of their blood pressure variations with implications for targeted interventions and timing of medications to improve prognosis.

  • JMIR Res Protoc 2020;9(1):e14820

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  RCTs - Protocols/Proposals (eHealth)

  Jan 17, 2020

  Using Augmented Reality to Motivate Oral Hygiene Practice in Children: Protocol for the Development of a Serious Game

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  Authors List:

  • Susy Nazaré Silva Ribeiro Amantini  
  • Alexandre Alberto Pascotto Montilha  
  • Bianca Caseiro Antonelli  
  • Kim Tanabe Moura Leite  
  • Daniela Rios  
  • Thiago Cruvinel  
  • Natalino Lourenço Neto  
  • Thais Marchini Oliveira  
  • Maria Aparecida Andrade Moreira Machado  

  Abstract:

  Background: New technologies create possible new ways of action, interaction, and learning which is extremely relevant in the field of oral health education. There is a lack of protocol in using an immersive interactive ludic-educational interface to motivate oral hygiene practice in children by means of augmented reality. Objective: This study aims to present a protocol on the development of a serious game to motivate oral hygiene practice in children. Methods: A serious game will be designed by augmented reality techniques to improve toothbrushing effectiveness of children aged 6 to 10 years. The functional structure of this interface is activated by means of movements recognized by Kinect (Microsoft Corp). The toothbrushing technique will be available in the game, enabling the children to execute the movement in the virtual environment. By identifying errors, this game will be tailored to improve the oral health of children by correcting the technique and teaching the user the adequate toothbrushing method. A template analysis will be performed to identify barriers and facilitators in each scenario. Results: After the implementation of the virtual interactive and immersive panels, enrollment will begin and evaluations will be made by means of questionnaires distributed to participants who interact with the game. Thus, an analysis of the product efficacy will be conducted. The expected outcome will be to obtain a digital instrument to motivate oral hygiene practice and enhance health awareness in children. Conclusions: The serious game will support the prevention of oral diseases by sharing scientific research in the school environment and community.

  • JMIR Res Protoc 2020;9(1):e10987

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  Non-Randomized Study Protocols and...

  Jan 15, 2020

  The Impact of Hearing Impairment on the Life Trajectories of Aboriginal Children in Remote Australia: Protocol for the Hearing Loss in Kids Project

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  Authors List:

  • Jiunn-Yih Su  
  • Vincent Yaofeng He  
  • Steven Guthridge  
  • Sven Silburn  

  Abstract:

  Background: Previous studies have reported a high prevalence of chronic otitis media (OM) and hearing impairment (HI) in Aboriginal children in the Northern Territory (NT) of Australia. Children affected by these disorders are believed to be at increased risk for adverse outcomes in early childhood development, school attendance, academic performance, and child maltreatment and youth offending. However, to date, there have been no studies quantifying the association between HI and these outcomes in this population. Objective: This study will investigate the association between HI and the 5 outcomes in Aboriginal children living in remote NT communities. Methods: Individual-level information linked across multiple administrative datasets will be used to conduct a series of retrospective observational studies on selected developmental and school outcomes. The predictor variables for all studies are the results from audiometric hearing assessments. The outcome measures are as follows: Australian Early Development Census results, representing developmental readiness for school, assessed around 5 years of age; Year 1 school attendance rates; Year 3 school-based academic performance, assessed in the National Assessment Program—Literacy and Numeracy; incidence of child maltreatment events (including both notifications and substantiated cases); and incidence of a first guilty verdict for youth offenders. Confounding and moderating factors available for the analysis include both community-level factors (including school fixed effects, socioeconomic status, level of remoteness, and housing crowdedness) and individual-level factors (including maternal and perinatal health and hospital admissions in early childhood). Results: The study commenced in 2018, with ethics and data custodian approvals for data access and linkage. This has enabled the completion of data linkage and the commencement of data analysis for individual component studies, with findings expected to be published in 2019 and 2020. Conclusions: This study will provide first evidence of the impact of OM-related HI on the developmental, educational, and social outcomes of Australian Aboriginal children. The findings are expected to have significant implications for policy development, service design, and resource allocation.

  • JMIR Res Protoc 2020;9(1):e15464

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  RCTs - Protocols/Proposals (funded,...

  Jan 14, 2020

  The Use of Web-Based Support Groups Versus Usual Quit-Smoking Care for Men and Women Aged 21-59 Years: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Cornelia Ann Pechmann  
  • Douglas Calder  
  • Connor Phillips  
  • Kevin Delucchi  
  • Judith J Prochaska  

  Abstract:

  Background: Existing smoking cessation treatments are challenged by low engagement and high relapse rates, suggesting the need for more innovative, accessible, and interactive treatment strategies. Twitter is a Web-based platform that allows people to communicate with each other throughout the day using their phone. Objective: This study aims to leverage the social media platform of Twitter for fostering peer-to-peer support to decrease relapse with quitting smoking. Furthermore, the study will compare the effects of coed versus women-only groups on women’s success with quitting smoking. Methods: The study design is a Web-based, three-arm randomized controlled trial with two treatment arms (a coed or women-only Twitter support group) and a control arm. Participants are recruited online and are randomized to one of the conditions. All participants will receive 8 weeks of combination nicotine replacement therapy (patches plus their choice of gum or lozenges), serial emails with links to Smokefree.gov quit guides, and instructions to record their quit date online (and to quit smoking on that date) on a date falling within a week of initiation of the study. Participants randomized to a treatment arm are placed in a fully automated Twitter support group (coed or women-only), paired with a buddy (matched on age, gender, location, and education), and encouraged to communicate with the group and buddy via daily tweeted discussion topics and daily automated feedback texts (a positive tweet if they tweet and an encouraging tweet if they miss tweeting). Recruited online from across the continental United States, the sample consists of 215 male and 745 female current cigarette smokers wanting to quit, aged between 21 and 59 years. Self-assessed follow-up surveys are completed online at 1, 3, and 6 months after the date they selected to quit smoking, with salivary cotinine validation at 3 and 6 months. The primary outcome is sustained biochemically confirmed abstinence at the 6-month follow-up. Results: From November 2016 to September 2018, 960 participants in 36 groups were recruited for the randomized controlled trial, in addition to 20 participants in an initial pilot group. Data analysis will commence soon for the randomized controlled trial based on data from 896 of the 960 participants (93.3%), with 56 participants lost to follow-up and 8 dropouts. Conclusions: This study combines the mobile platform of Twitter with a support group for quitting smoking. Findings will inform the efficacy of virtual peer-to-peer support groups for quitting smoking and potentially elucidate gender differences in quit rates found in prior research. Clinical Trial: ClinicalTrials.gov NCT02823028; https://clinicaltrials.gov/ct2/show/NCT02823028

  • JMIR Res Protoc 2020;9(1):e16417

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  RCTs - Protocols/Proposals (funded,...

  Jan 14, 2020

  Effects of Bluetooth-Enabled Desk Ellipticals on Office Work Performance: Rationale, Design, and Protocol for a Randomized Trial With Overweight and Obese...

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  Authors List:

  • Liza S Rovniak  
  • Marc A Adams  
  • Christopher N Sciamanna  
  • Lan Kong  
  • Nicole Sullivan  
  • Sara Costalas  
  • Melissa Bopp  
  • Ashley Kuzmik  

  Abstract:

  Background: Workplaces that provide opportunities for physical activity without requiring extra time for activity could help counteract the obesity epidemic. Desk ellipticals can contribute to activity-supportive workplace environments; however, the feasibility of engaging employees in pedaling ellipticals during simultaneous office work has not been well evaluated. Objective: We aim to present the rationale and methods from an ongoing randomized trial with overweight and obese employees that will evaluate (1) the effects of pedaling a compact desk elliptical on work performance and (2) the influence of different incentive types and schedules on desk pedaling quantity. Methods: Overweight and obese medical center employees are being recruited in dyads for a 2 (gift card type: healthier food vs Amazon) by 3 (gift card schedule: immediate incentive contingent on individual pedaling quantity; immediate incentive partially contingent on dyads’ joint pedaling quantity; and delayed noncontingent pedaling incentive) cluster randomized within-subjects factorial trial. All participants receive a Bluetooth-enabled desk elliptical for 4 weeks and access to a mobile app that provides real-time pedaling feedback. The primary aims are to assess (1) change in employee work performance from pre- to postelliptical installation via employee and supervisor ratings and (2) effects of gift card type and schedule on quantity of objectively measured desk pedaling completed. Results: Data collection is ongoing. We expect to complete main outcome analyses in 2020. Conclusions: This trial represents one of the earliest attempts to assess the effects of desk pedaling and pedaling-incentive types in real-world offices. It could help bridge the research-to-practice gap by providing evidence on whether desk pedaling can be sustained without compromising work performance.

  • JMIR Res Protoc 2020;9(1):e16275

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  RCTs - Protocols/Proposals (non-eHealth)

  Jan 13, 2020

  Behavioral, Nutritional, and Genetic Risk Factors of Colorectal Cancers in Morocco: Protocol for a Multicenter Case-Control Study

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  Authors List:

  • Meimouna Mint Sidi Ould Deoula  
  • Inge Huybrechts  
  • Khaoula El Kinany  
  • Hanae Boudouaya  
  • Zineb Hatime  
  • Achraf El Asri  
  • Abdelilah Benslimane  
  • Chakib Nejjari  
  • Ibrahimi Sidi Adil  
  • Karima El Rhazi  

  Abstract:

  Background: Colorectal cancer (CRC) has been reported as the third most commonly diagnosed cancer worldwide and is currently considered as a major public health concern. A peak increase in incidence has been noted in economically transitioning countries like Morocco where industrialization started shifting from a traditional lifestyle and diet toward a more westernized diet and lifestyle. Objective: This paper aims to present the protocol of a large-scale Moroccan case-control study that aims at investigating associations of diet, other lifestyle factors, and genetic traits with CRC risk in Morocco. Methods: A case-control study was conducted between 2009 and 2017, including 3032 case-control pairs (1516 cases and 1516 controls) matched on sex, age, and center in 5 major public health hospitals in Morocco. Questionnaires on sociodemographic data, lifestyle, family history of CRC, and nonsteroidal anti-inflammatory drugs (NSAIDs) were completed by trained investigators during face-to-face interviews. In addition, participants completed a semiquantitative food-frequency questionnaire, developed to assess food intake in the Moroccan population. Information regarding genetic factors was recorded for cases, and paraffin blocks (with embedded tumor tissues) are available in 3 collaborating hospitals. Conditional logistic regression analysis is planned to assess associations between diet and CRC risk. Binary logistic regression is considered to predict associations between mutations and nutritional risk factors including only CRC case series. Results: Altogether, 2966 cases-control pairs (1483 cases and 1483 controls) were considered eligible and included in this study. Both cases and controls did not differ significantly with respect to age (P=.36), sex (P=.51), center (P>.99), marital status (P=.30), and NSAID use (P=.08). However, participants in the control group were significantly more likely to have a high income level and live in urban areas and to have a high level of education than cases. Conclusions: This is the first study investigating potential risk factors of CRC such as lifestyle, diet, and genetic factors, originating from a southern Mediterranean country with low but increasing CRC prevalence. Identified risk factors allow the establishment of evidence-based preventive actions regarding nutrition and other lifestyle habits adapted to the Moroccan context. In brief, this study will promote cancer research and prevention in Morocco.

  • JMIR Res Protoc 2020;9(1):e13998

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  Non-randomized Protocols and Methods...

  Jan 13, 2020

  Evaluation of a Health Information Technology–Enabled Panel Management Platform to Improve Anticoagulation Control in a Low-Income Patient Population:...

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  Authors List:

  • Valy Fontil  
  • Dhruv Kazi  
  • Roy Cherian  
  • Shin-Yu Lee  
  • Urmimala Sarkar  

  Abstract:

  Background: Warfarin is one of the most commonly prescribed medications in the United States, and it causes a significant proportion of adverse drug events. Patients taking warfarin fall outside of the recommended therapeutic range 30% of the time, largely because of inadequate laboratory monitoring and dose adjustment. This leads to an increased risk of blood clots or bleeding events. We propose a comparative effectiveness study to examine whether a technology-enabled anticoagulation management program can improve long-term clinical outcomes compared with usual care. Objective: Our proposed intervention is the implementation of an electronic dashboard (integrated into a preexisting electronic health record) and standardized workflow to track patients’ laboratory results, identify patients requiring follow-up, and facilitate the use of a validated nomogram for dose adjustment. The primary outcome of this study is the time in therapeutic range (TTR) at 6 months post intervention (a validated metric of anticoagulation quality among patients receiving warfarin). Methods: We will employ a pre-post quasi-experimental design with a nonequivalent usual-care comparison site and a difference-in-differences approach to compare the effectiveness of a technology-enabled anticoagulation management program compared with usual care at a large university-affiliated safety-net clinic. Results: We used a commercially available health information technology (HIT) platform to host a registry of patients on warfarin therapy and create the electronic dashboard for panel management. We developed the intervention with, and for, frontline clinician users, using principles of human-centered design. This study is funded until September 2020 and is approved by the University of California, San Francisco Institutional Review Board until June 22, 2020. We completed data collection in September 2019 and expect to complete our proposed analyses by February 2020. Conclusions: We anticipate that the intervention will increase TTR among patients taking warfarin and that the use of this HIT platform will facilitate tracking and monitoring of patients on warfarin, which could enable outreach to those overdue for visits or laboratory monitoring. We will use these findings to iteratively improve the platform in preparation for a larger, multiple-site, pragmatic clinical trial. If successful, our study will demonstrate the integration of HIT platforms into existing electronic health records to improve patient care in real-world clinical settings.

  • JMIR Res Protoc 2020;9(1):e13835

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  Non-Randomized Study Protocols and...

  Jan 10, 2020

  Testing the Effectiveness of Enhanced Alcohol Warning Labels and Modifications Resulting From Alcohol Industry Interference in Yukon, Canada: Protocol for a...

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  Authors List:

  • Kate Vallance  
  • Timothy Stockwell  
  • David Hammond  
  • Simran Shokar  
  • Nour Schoueri-Mychasiw  
  • Thomas Greenfield  
  • Jonathan McGavock  
  • Jinhui Zhao  
  • Ashini Weerasinghe  
  • Erin Hobin  

  Abstract:

  Background: Alcohol warning labels are a promising, well-targeted strategy to increase public awareness of alcohol-related health risks and support more informed and safer use. However, evidence of their effectiveness in real-world settings remains limited and inconclusive. Objective: This paper presents a protocol for a real-world study examining the population-level impact of enhanced alcohol warning labels with a cancer message; national drinking guidelines; and standard drink information on attention, processing, and alcohol-related behaviors among consumers in Canada. Postimplementation modifications to the original protocol due to interference by national alcohol industry representatives are also described. Methods: This quasi-experimental study involved partnering with local governments in two northern Canadian territories already applying alcohol warning labels on alcohol containers for sale in liquor stores. The study tested an 8-month intervention consisting of three new enhanced, rotating alcohol warning labels in an intervention site (Whitehorse, Yukon) relative to a comparison site (Yellowknife, Northwest Territories) where labelling practices would remain unchanged. Pre-post surveys were conducted at both sites to measure changes in awareness and processing of label messages, alcohol-related knowledge, and behaviors. Liquor store transaction data were collected from both sites to assess changes in population-level alcohol consumption. The intervention was successfully implemented for 1 month before it was halted due to complaints from the alcohol industry. The government of the intervention site allowed the study to proceed after a 2-month pause, on the condition that the cancer warning label was removed from rotation. Modifications to the protocol included applying the two remaining enhanced labels for the balance of the intervention and adding a third wave of surveys during the 2-month pause to capture any impact of the cancer label. Results: This study protocol describes a real-world quasi-experimental study that aimed to test the effectiveness of new enhanced alcohol warning labels as a tool to support consumers in making more informed and safer alcohol choices. Alcohol industry interference shortly after implementation compromised both the intervention and the original study design; however, the study design was modified to enable completion of three waves of surveys with cohort participants (n=2049) and meet the study aims. Conclusions: Findings from this study will directly inform alcohol labelling policies in Canada and internationally and provide further insight into the alcohol industry’s attempts to disrupt research in this area. Additional unimpeded real-world evaluations of enhanced alcohol warning labels are recommended.

  • JMIR Res Protoc 2020;9(1):e16320

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  RCTs - Protocols/Proposals (eHealth)

  Jan 10, 2020

  Caring Near and Far by Connecting Community-Based Clients and Family Member/Friend Caregivers Using Passive Remote Monitoring: Protocol for a Pragmatic...

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  Authors List:

  • Lorie Donelle  
  • Sandra Regan  
  • Michael Kerr  
  • Merrick Zwarenstein  
  • Michael Bauer  
  • Grace Warner  
  • Wanrudee Isaranuwatchai  
  • Aleksandra Zecevic  
  • Elizabeth Borycki  
  • Dorothy Forbes  
  • Lori Weeks  
  • Bev Leipert  
  • Emily Read  

  Abstract:

  Background: Significant chronic disease challenges exist among older adults. However, most older adults want to remain at home even if their health conditions challenge their ability to live independently. Yet publicly funded home care resources are scarce, private home care is expensive, and family/friend caregivers have limited capacity. Many older adults with chronic illness would require institutional care without the support from family member/friend caregivers. This role raises the risk of physical health problems, stress, burnout, and depression. Passive remote monitoring (RM), the use of sensors that do not require any action by the individual for the system to work, may increase the older adult’s ability to live independently while also providing support and peace of mind to both the client and the family member/friend caregiver. Objective: This paper presents the protocol of a study conducted in two provinces in Canada to investigate the impact of RM along with usual home care (the intervention) versus usual home care alone (control) on older adults with complex care. The primary outcome for this study is the occurrence of and time to events such as trips to emergency, short-term admission to the hospital, terminal admission to the hospital awaiting admission to long-term care, and direct admission to long-term care. The secondary outcomes for this study are (1) health care costs, (2) client functional status and quality of life in the home, (3) family/friend caregiver stress, and (4) family/friend caregiver functional health status. Methods: The design for this study is an unblinded pragmatic randomized controlled trial (PRCT) with two parallel arms in two geographic strata (Ontario and Nova Scotia). Quantitative and qualitative methodologies will be used to address the study objectives. This PRCT is conceptually informed by the principles of client-centered care and viewing the family as the client and aims at providing supported self-management. Results: This study is supported by the Canadian Institutes for Health Research. A primary completion date is anticipated in fall 2022. Conclusions: Findings from this real-world rigorous randomized trial will support Canadian decision-makers, providers, and clients and their caregivers in assessing the health, well-being, and economic benefits and the social and technological challenges of integrating RM technologies to support older adults to stay in their home, including evaluating the impact on the burden of care experienced by family/friend caregivers. With an aging population, this technology may reduce institutionalization and promote safe and independent living for the elderly as long as possible. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 79884651; http://www.isrctn.com/ISRCTN79884651

  • JMIR Res Protoc 2020;9(1):e15027

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  RCTs - Protocols/Proposals (funded,...

  Jan 9, 2020

  Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized...

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  Authors List:

  • Andrew Gumley  
  • Simon Bradstreet  
  • John Ainsworth  
  • Stephanie Allan  
  • Mario Alvarez-Jimenez  
  • Louise Beattie  
  • Imogen Bell  
  • Max Birchwood  
  • Andrew Briggs  
  • Sandra Bucci  
  • Emily Castagnini  
  • Andrea Clark  
  • Sue M Cotton  
  • Lidia Engel  
  • Paul French  
  • Reeva Lederman  
  • Shon Lewis  
  • Matthew Machin  
  • Graeme MacLennan  
  • Claire Matrunola  
  • Hamish McLeod  
  • Nicola McMeekin  
  • Cathrine Mihalopoulos  
  • Emma Morton  
  • John Norrie  
  • Frank Reilly  
  • Matthias Schwannauer  
  • Swaran P Singh  
  • Lesley Smith  
  • Suresh Sundram  
  • David Thomson  
  • Andrew Thompson  
  • Helen Whitehill  
  • Alison Wilson-Kay  
  • Christopher Williams  
  • Alison Yung  
  • John Farhall  
  • John Gleeson  

  Abstract:

  Background: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. Objective: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. Methods: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Results: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. Conclusions: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262

  • JMIR Res Protoc 2020;9(1):e15058

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  RCTs - Protocols/Proposals (eHealth)

  Jan 8, 2020

  Factors Associated With Trial Completion and Adherence in App-Based N-of-1 Trials: Protocol for a Randomized Trial Evaluating Study Duration, Notification...

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  Authors List:

  • Jason R Bobe  
  • Jacqueline Buros  
  • Eddye Golden  
  • Matthew Johnson  
  • Michael Jones  
  • Bethany Percha  
  • Ryan Viglizzo  
  • Noah Zimmerman  

  Abstract:

  Background: N-of-1 trials promise to help individuals make more informed decisions about treatment selection through structured experiments that compare treatment effectiveness by alternating treatments and measuring their impacts in a single individual. We created a digital platform that automates the design, administration, and analysis of N-of-1 trials. Our first N-of-1 trial, the app-based Brain Boost Study, invited individuals to compare the impacts of two commonly consumed substances (caffeine and L-theanine) on their cognitive performance. Objective: The purpose of this study is to evaluate critical factors that may impact the completion of N-of-1 trials to inform the design of future app-based N-of-1 trials. We will measure study completion rates for participants that begin the Brain Boost Study and assess their associations with study duration (5, 15, or 27 days) and notification level (light or moderate). Methods: Participants will be randomized into three study durations and two notification levels. To sufficiently power the study, a minimum of 640 individuals must begin the study, and 97 individuals must complete the study. We will use a multiple logistic regression model to discern whether the study length and notification level are associated with the rate of study completion. For each group, we will also compare participant adherence and the proportion of trials that yield statistically meaningful results. Results: We completed the beta testing of the N1 app on a convenience sample of users. The Brain Boost Study on the N1 app opened enrollment to the public in October 2019. More than 30 participants enrolled in the first month. Conclusions: To our knowledge, this will be the first study to rigorously evaluate critical factors associated with study completion in the context of app-based N-of-1 trials. Clinical Trial: ClinicalTrials.gov NCT04056650; https://clinicaltrials.gov/ct2/show/NCT04056650

  • JMIR Res Protoc 2020;9(1):e16362

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  Non-Randomized Study Protocols and...

  Jan 8, 2020

  Developing an Evidence-Based Nursing Handover Standard for a Multi-Site Public Hospital in Switzerland: Protocol for a Web-Based, Modified Delphi Study

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  Authors List:

  • Nadine Tacchini-Jacquier  
  • Els de Waele  
  • Peter Urben  
  • Pierre Turini  
  • Henk Verloo  

  Abstract:

  Background: Poor communication processes create opportunities for errors when caregivers fail to transfer complete and consistent information. Inadequate or nonexistent clinical handovers or failures to transfer information, responsibility, and accountability can have dire consequences for hospitalized patients. Clinical handover is practiced every day, in a multitude of ways, in all health care settings. Objective: The goal of this study is to build a consensus, evidence-based nursing handover standard for inpatients during shift changes or internal transfers between hospital wards. The study will be based on papers published by Slade et al. Methods: This protocol describes a modified Delphi data-collection survey involving a targeted panel sample of 300 nurse experts. A multi-round survey will select an anonymous panel from a multi-site public hospital in Switzerland. Each survey stage will be described and will build on the previous one. The study will end with a focus group discussion involving a randomly selected panel to explain why items for the evidence-based clinical nursing handover standard were accepted or not accepted. An item must achieve a consensus of ≥70% for inclusion. Results: The present study’s expected outcome is a consensus-built, evidence-based nursing handover standard for inpatients during shift changes or internal transfers between the wards of a multi-site public hospital in Switzerland. Conclusions: This survey will enable us to develop an evidence-based nursing handover standard for use during shift changes and internal inpatient transfers in a multi-site public hospital in Switzerland.

  • JMIR Res Protoc 2020;9(1):e15910

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