JMIR Publications

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  RCTs - Protocols/Proposals (eHealth)

  Apr 18, 2019

  Reducing Alcohol Consumption Among Risky Drinkers in the General Population of Sweden Using an Interactive Mobile Health Intervention: Protocol for a...

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  Authors List:

  • Marcus Bendtsen  
  • Jim McCambridge  

  Abstract:

  Background: Harmful use of alcohol continues to be a leading contributor to premature deaths globally. Not only does harmful drinking have consequences for the individuals consuming at increased levels, but it may also result in a range of negative consequences for their family members and friends. Interventions delivered via mobile phones (mobile health [mHealth] interventions) could potentially support risky drinkers seeking help to reduce their alcohol consumption. Objective: This protocol describes a randomized controlled trial that aims to validly estimate the effect of a novel mHealth intervention targeting risky drinkers in the general population of Sweden. Nested within the trial are 3 substudies that focus on methodological and user satisfaction research questions. Methods: A 2-arm parallel group randomized controlled trial will be employed to estimate the effect of the novel intervention. Participants will be recruited through Web advertisements and social media. The inclusion criteria are as follows: 18 years or older, ownership of a mobile phone, and being classified as a risky drinker according to Swedish guidelines. Participants allocated to the intervention group will receive a novel mHealth intervention. The intervention consists of weekly screening, personalized feedback on current consumption, functions allowing for planning of future consumption, as well as a series of messages delivered throughout the week. Participants allocated to the control group will receive a short message regarding negative consequences of alcohol consumption and a hyperlink that offers more information. Following 2 and 4 months after randomization, both groups will be asked to complete follow-up questionnaires (2-month interval being primary). Primary outcomes are weekly alcohol consumption and heavy episodic drinking. Participants in the control group will be given access to the novel intervention after completing the 4-month follow-up. The trial includes 3 substudies: We will explore whether the mode of presenting information before participants giving informed consent affects participation rates and recall of trial parameters, investigate if the content of the short message received by the control group affects study outcomes and requests for more information, and explore user satisfaction with the intervention and reactions of the control group. Results: Participant recruitment is planned to begin in April 2019 and to last for a maximum of 24 months. The first dataset will be available approximately 2 months after the final participant has been recruited, and the final dataset will be available approximately 2 months later. No participants had been recruited at the time of submitting this protocol. Conclusions: If found effective, the intervention has the potential to reduce negative consequences of alcohol consumption for individuals. The technology has been designed to have potential for extensive reach among those who may benefit. Trial Registration: ISRCTN Registry ISRCTN48317451; http://www.isrctn.com/ISRCTN48317451 (Archived by WebCite at http://www.webcitation.org/779tKLsu3) International Registered Report Identifier (IRRID): PRR1-10.2196/13119

  • JMIR Res Protoc 2019;8(4):e13119

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  Protocols/Grant Proposals (JMIR Res...

  Apr 17, 2019

  Dignity Therapy Led by Nurses or Chaplains for Elderly Cancer Palliative Care Outpatients: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Sheri Kittelson  
  • Lisa Scarton  
  • Paige Barker  
  • Joshua Hauser  
  • Sean O'Mahony  
  • Michael Rabow  
  • Marvin Delgado Guay  
  • Tammie E Quest  
  • Linda Emanuel  
  • George Fitchett  
  • George Handzo  
  • Yingewi Yao  
  • Harvey Max Chochinov  
  • Diana Wilkie  

  Abstract:

  Background: Our goal is to improve psychosocial and spiritual care outcomes for elderly patients with cancer by optimizing an intervention focused on dignity conservation tasks such as settling relationships, sharing words of love, and preparing a legacy document. These tasks are central needs for elderly patients with cancer. Dignity therapy (DT) has clear feasibility but inconsistent efficacy. DT could be led by nurses or chaplains, the 2 disciplines within palliative care that may be most available to provide this intervention; however, it remains unclear how best it can work in real-life settings. Objective: We propose a randomized clinical trial whose aims are to (1) compare groups receiving usual palliative care for elderly patients with cancer or usual palliative care with DT for effects on (a) patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness); and (b) processes of delivering palliative spiritual care services (satisfaction and unmet spiritual needs); and (2) explore the influence of physical symptoms and spiritual distress on the outcome effects (dignity impact and existential tasks) of usual palliative care and nurse- or chaplain-led DT. We hypothesize that, controlling for pretest scores, each of the DT groups will have higher scores on the dignity impact and existential task measures than the usual care group; each of the DT groups will have better peaceful awareness and treatment preference more consistent with their cancer prognosis than the usual care group. We also hypothesize that physical symptoms and spiritual distress will significantly affect intervention effects. Methods: We are conducting a 3-arm, pre- and posttest, randomized, controlled 4-step, stepped-wedge design to compare the effects of usual outpatient palliative care and usual outpatient palliative care along with either nurse- or chaplain-led DT on patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness). We will include 560 elderly patients with cancer from 6 outpatient palliative care services across the United States. Using multilevel analysis with site, provider (nurse, chaplain), and time (step) included in the model, we will compare usual care and DT groups for effects on patient outcomes and spiritual care processes and determine the moderating effects of physical symptoms and spiritual distress. Results: The funding was obtained in 2016, with participant enrollment starting in 2017. Results are expected in 2021. Conclusions: This rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research for elderly cancer patients. Trial Registration: ClinicalTrials.gov NCT03209440; https://clinicaltrials.gov/ct2/show/NCT03209440 International Registered Report Identifier (IRRID): DERR1-10.2196/12213

  • JMIR Res Protoc 2019;8(4):e12213

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  Theme Issue (2018): Adolescent...

  Apr 16, 2019

  Model-Based Methods to Translate Adolescent Medicine Trials Network for HIV/AIDS Interventions Findings Into Policy Recommendations: Rationale and Protocol...

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  Authors List:

  • Anne M Neilan  
  • Kunjal Patel  
  • Allison L Agwu  
  • Ingrid V Bassett  
  • K. Rivet Amico  
  • Catherine M Crespi  
  • Aditya H Gaur  
  • Keith J Horvath  
  • Kimberly A Powers  
  • H Jonathon Rendina  
  • Lisa B Hightow-Weidman  
  • Xiaoming Li  
  • Sylvie Naar  
  • Sharon Nachman  
  • Jeffrey T Parsons  
  • Kit N Simpson  
  • Bonita F Stanton  
  • Kenneth A Freedberg  
  • Audrey C Bangs  
  • Michael G Hudgens  
  • Andrea L Ciaranello  

  Abstract:

  Background: The United States Centers for Disease Control and Prevention estimates that approximately 60,000 US youth are living with HIV. US youth living with HIV (YLWH) have poorer outcomes compared with adults, including lower rates of diagnosis, engagement, retention, and virologic suppression. With Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) support, new trials of youth-centered interventions to improve retention in care and medication adherence among YLWH are underway. Objective: This study aimed to use a computer simulation model, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent Model, to evaluate selected ongoing and forthcoming ATN interventions to improve viral load suppression among YLWH and to define the benchmarks for uptake, effectiveness, durability of effect, and cost that will make these interventions clinically beneficial and cost-effective. Methods: This protocol, ATN 161, establishes the ATN Modeling Core. The Modeling Core leverages extensive data—already collected by successfully completed National Institutes of Health–supported studies—to develop novel approaches for modeling critical components of HIV disease and care in YLWH. As new data emerge from ongoing ATN trials during the award period about the effectiveness of novel interventions, the CEPAC-Adolescent simulation model will serve as a flexible tool to project their long-term clinical impact and cost-effectiveness. The Modeling Core will derive model input parameters and create a model structure that reflects key aspects of HIV acquisition, progression, and treatment in YLWH. The ATN Modeling Core Steering Committee, with guidance from ATN leadership and scientific experts, will select and prioritize specific model-based analyses as well as provide feedback on derivation of model input parameters and model assumptions. Project-specific teams will help frame research questions for model-based analyses as well as provide feedback regarding project-specific inputs, results, sensitivity analyses, and policy conclusions. Results: This project was funded as of September 2017. Conclusions: The ATN Modeling Core will provide critical information to guide the scale-up of ATN interventions and the translation of ATN data into policy recommendations for YLWH in the United States.

  • JMIR Res Protoc 2019;8(4):e9898

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  SSHRC funded proposals with...

  Apr 16, 2019

  Mobility and Participation of People With Disabilities Using Mobility Assistive Technologies: Protocol for a Mixed-Methods Study

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  Authors List:

  • François Routhier  
  • W Ben Mortenson  
  • Louise Demers  
  • Atiya Mahmood  
  • Habib Chaudhury  
  • Kathleen A Martin Ginis  
  • William C Miller  

  Abstract:

  Background: Many community-dwelling individuals living with a disability use mobility assistive technologies (MATs). MAT devices are generally beneficial for individuals with mobility impairments. However, less is known about the specific factors that may foster or deter mobility and community participation. Objective: The purpose of this protocol is to describe the methodology for a study including three main objectives: (1) to understand the places people using MAT go and the things they do, (2) to identify perceived barriers and facilitators as well as users’ desired environmental modifications, and (3) to understand subjective and objective issues related to environmental accessibility. Methods: A mixed-methods study was conducted in Vancouver and in Quebec City. Qualitative interviews were conducted to address all three objectives. In addition, Objective 1 was achieved through collection of global positioning system (GPS) data and activity diaries with 36 participants per site who represented six types of MAT users (ie, cane, walker, crutches, manual wheelchair, power wheelchair, and scooter). All participants were invited to take part in all aspects of data collection. PhotoVoice was used to address Objectives 2 and 3. Two environmental audits were used to address Objective 2. The Stakeholders’ Walkability/Wheelability Audit in Neighbourhood (SWAN) measured perceptions related to a variety of community environmental features associated with mobility and participation. A total of 24 participants were recruited to each study site for SWAN data collection. The Measure of Environmental Accessibility (MEA) was also used to objectively measure access to exterior and interior environments selected earlier in the project by the participants that could benefit from improvements. Results: Funding for this study was obtained from the Social Sciences and Humanities Research Council of Canada. Approval was obtained from the University of British Columbia Research Ethics Board and the Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale Research Ethics Board. Regarding the MEA evaluations, 19 locations (ie, buildings and exterior spaces) where obstacles have been identified by the participants of the PhotoVoice focus groups have been evaluated in Quebec City and 20 locations have been identified in the Vancouver region by the participants of the community forums. Data collection for this project was completed in December 2018. Analysis and writing of manuscripts are underway. Conclusions: The use of a variety of methods to gather data on participation and mobility will allow a more holistic consideration of factors influencing mobility with a MAT device. This study will provide objective information about the mobility of participants and identify barriers and facilitators that impact their mobility and community participation. Through the mixed-methods approach employed in this study, we will gain a subjective evaluation of the participants’ neighborhoods, including personally meaningful information on environmental features that influence participants' everyday mobility and participation. We will also gain an objective evaluation of particular obstacles that community users of MAT identify as significant barriers to their ability to access public environments. We anticipate that these findings will help to identify a broad spectrum of solutions to improve the mobility and community participation of MAT users. International Registered Report Identifier (IRRID): DERR1-10.2196/12089

  • JMIR Res Protoc 2019;8(4):e12089

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  Non-randomized Protocols and Methods...

  Apr 15, 2019

  Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary...

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  Authors List:

  • Christian Mueller  
  • Barbara Stollfuss  
  • Alexander Roitenberg  
  • Jonas Harder  
  • Manuel J Richter  

  Abstract:

  Background: Pulmonary arterial hypertension (PAH)—a progressive, ultimately fatal disease—patients often experience dyspnea, which can limit their daily physical activities. Iloprost is an inhaled therapy for PAH that has shown efficacy in clinical trials. However, clinical trials in PAH have provided only limited data on daily physical activity. Digital monitoring of daily physical activity in PAH is therefore attracting growing interest. To fully understand a patient’s response to treatment, monitoring of treatment adherence is also required. The Breelib nebulizer for administration of iloprost saves inhalation data, thus allowing digital monitoring of adherence. Objective: This study aims to perform parallel digital tracking of daily physical activity parameters, heart rate, and iloprost inhalation data in patients with PAH, before and after starting inhaled iloprost treatment. The primary objective is to investigate correlations between changes in digital measures of daily physical activity and traditional clinical measures. Secondary objectives are to assess iloprost inhalation behavior, the association between daily physical activity measures and time since last inhalation, changes in sleep quality and heart rate, the association of heart rate with daily physical activity measures and iloprost inhalation, and adverse events. Methods: VENTASTEP is a digital, prospective, observational, multicenter, single-arm cohort study of adults with PAH in Germany, starting inhaled iloprost treatment via the Breelib nebulizer, in addition to existing PAH therapy. The study comprises a baseline period without iloprost treatment (≤2 weeks) and an observation period with iloprost treatment (3 months±2 weeks). The Apple Watch Series 2 and iPhone 6s are used with a dedicated study app to continuously measure digital daily physical activity parameters and heart rate during the baseline and observation periods; the watch is also used with a 6-min walk distance (6MWD) app to measure digital 6MWD at baseline and the end-of-observation visit. Inhalation frequency, completeness, and duration are monitored digitally via the nebulizer and the BreeConnect app. Sleep quality is assessed using the Pittsburgh Sleep Quality Index at baseline and the end-of-observation visit. Changes in traditional outcome measures (6MWD, Borg dyspnea scale, EuroQol 5-dimensions questionnaire, functional class, and brain natriuretic peptide [BNP] or N-terminal proBNP) between baseline and the end-of-observation visit will be correlated with changes in digital daily physical activity parameters and digital 6MWD as the primary analysis. Results: The first participant was enrolled in February 2018 (estimated study completion by July 2019; planned sample size: 80 patients). Conclusions: The VENTASTEP study will inform future research on the utility of digital parameters as outcome assessment tools for disease monitoring in PAH. The study will also provide insight into clinical outcomes, daily physical activity, and quality of life in patients adding inhaled iloprost, to existing PAH therapy. Trial Registration: ClinicalTrials.gov NCT03293407; https://clinicaltrials.gov/ct2/show/NCT03293407 (Archived by WebCite at http://www.webcitation.org/6ywPGcn4I) International Registered Report Identifier (IRRID): DERR1-10.2196/12144

  • JMIR Res Protoc 2019;8(4):e12144

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  Non-randomized Protocols and Methods...

  Apr 15, 2019

  Exposure to Potentially Harmful E-Cigarette Emissions via Vape Tricks: Protocol for a Mixed-Methods Study

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  Authors List:

  • Robert Furberg  
  • Alexa M Ortiz  
  • Michelle McCombs  
  • Margaret Cress  
  • Jonathan Thornburg  
  • Jessica K Pepper  
  • Youn Ok Lee  

  Abstract:

  Background: The number of adolescents and adults using e-cigarettes, referred to as vaping, has dramatically increased. E-cigarettes can be used to perform vape tricks by inhaling and exhaling the e-cigarette aerosol in patterns to create visual effects or large clouds. To create these effects, the puffing patterns associated with vape tricks may be different than standard ad-lib e-cigarette usage. The prevalence of vape tricks and the harm associated with exposure to e-cigarette emissions when performing vape tricks is currently unknown. Objective: Our objectives are to characterize duration, heart rate, respiratory rate, tidal volume, minute volume, and physical activity metrics associated with the performance of vape tricks and to characterize the emission of e-cigarettes when performing vape tricks in a manner suitable to inform novel exposure modeling. Methods: The study will recruit e-cigarette users with a history of performing vape tricks. Data collection will occur in two different sessions. In the first session, participants will be asked to puff on their e-cigarette as they normally would for 20 minutes. The second session will be a vape tricks session, where users will be asked to perform a series of up to five different vape tricks with their e-cigarette. Data will be collected through screener surveys, in-person interviews, video recordings, a personal exposure monitor, and a biometric garment. Results: Data analysis is pending and scheduled to take place in the fall of 2019. Conclusions: This study will be used to assess the feasibility of using a biometric garment to complement environmental and observational data. The approach may provide greater insight into the health risks of performing vape tricks compared to typical e-cigarette use. International Registered Report Identifier (IRRID): DERR1-10.2196/12304

  • JMIR Res Protoc 2019;8(4):e12304

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  RCTs - Protocols/Proposals (eHealth)

  Apr 12, 2019

  Protocol for the Inroads Study: A Randomized Controlled Trial of an Internet-Delivered, Cognitive Behavioral Therapy–Based Early Intervention to Reduce...

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  Authors List:

  • Lexine A Stapinski  
  • Katrina Prior  
  • Nicola C Newton  
  • Mark Deady  
  • Erin Kelly  
  • Briana Lees  
  • Maree Teesson  
  • Andrew J Baillie  

  Abstract:

  Background: The transition to adulthood is a unique developmental period characterized by numerous personal and social role changes and increased opportunities for alcohol consumption. Using alcohol to cope with anxiety symptoms is commonly reported, and young people with anxiety are at a greater risk of hazardous alcohol use and progression to alcohol use disorder. Anxiety and alcohol use tend to fuel each other in an exacerbating feed-forward cycle, leading to difficult-to-treat chronic problems. The peak in onset of anxiety and alcohol disorders suggests this developmental window represents a promising opportunity for early intervention before these problems become entrenched. Objective: This study aims to evaluate the efficacy of the Inroads program, a therapist-supported, internet-delivered early intervention for young adults that targets alcohol use, anxiety symptoms, and the interconnections between these problems. Methods: A randomized controlled trial will be conducted nationally among young Australians (aged 17-24 years) who experience anxiety symptoms and drink alcohol at hazardous or harmful levels. Participants will be individually randomized on a 1:1 basis to receive the Inroads intervention or assessment plus alcohol guidelines. Participants randomized to the Inroads intervention will receive access to 5 Web-based cognitive behavioral therapy (CBT) modules and weekly therapist support via email and/or phone. The primary outcome assessment will be 8 weeks post baseline, with follow-up assessment 6 months post baseline to determine the sustainability of the intervention effects. Primary outcomes will be the total number of standard drinks consumed in the past month (assessed by the Timeline Follow-Back procedure), severity of alcohol-related harms (assessed by the Brief Young Adult Alcohol Consequences Questionnaire), and anxiety symptoms across multiple disorders (assessed by the Generalized Anxiety Disorder-7). Secondary outcomes will include alcohol outcome expectancies; functional impairment and quality of life; and symptoms of social anxiety, anxious arousal, and depression. Results will be analyzed by intention-to-treat using multilevel mixed effects analysis for repeated measures. Results: The study is funded from 2017 to 2020 by Australian Rotary Health. Recruitment is expected to be complete by late-2018, with the 6-month follow-ups to be completed by mid-2019. Results are expected to be published in 2020. Conclusions: The study will be the first to evaluate the benefits of a youth-focused early intervention that simultaneously targets anxiety and hazardous alcohol use. By explicitly addressing the interconnections between anxiety and alcohol use and enhancing CBT coping skills, the Inroads program has the potential to interrupt the trajectory toward co-occurring anxiety and alcohol use disorders. The Web-based format of the program combined with minimal therapist support means that if effective, the program could be widely disseminated to reach young people who are not currently able or willing to access face-to-face treatment. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12617001609347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372748&isReview=true (Archived by WebCite at http://www.webcitation.org/77Au19jmf) International Registered Report Identifier (IRRID): DERR1-10.2196/12370

  • JMIR Res Protoc 2019;8(4):e12370

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  RCTs - Protocols/Proposals (funded,...

  Apr 11, 2019

  Process Evaluation of a Medical Student–Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster...

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  Authors List:

  • Titus Josef Brinker  
  • Fabian Buslaff  
  • Janina Leonie Suhre  
  • Marc Philipp Silchmüller  
  • Evgenia Divizieva  
  • Jilada Wilhelm  
  • Gabriel Hillebrand  
  • Dominik Penka  
  • Benedikt Gaim  
  • Susanne Swoboda  
  • Sonja Baumermann  
  • Jörg Werner Walther  
  • Christian Martin Brieske  
  • Lena Jakob  
  • Hannah Maria Baumert  
  • Ole Anhuef  
  • Selina Marisa Schmidt  
  • Jonas Alfitian  
  • Anil Batra  
  • Lava Taha  
  • Ute Mons  
  • Felix Johannes Hofmann  
  • Ailís Ceara Haney  
  • Caelán Max Haney  
  • Samuel Schaible  
  • Thien-An Tran  
  • Hanna Beißwenger  
  • Tobias Stark  
  • David A Groneberg  
  • Werner Seeger  
  • Aayushi Srivastava  
  • Henning Gall  
  • Julia Holzapfel  
  • Nancy A Rigotti  
  • Tanja Gabriele Baudson  
  • Alexander H Enk  
  • Stefan Fröhling  
  • Christof von Kalle  
  • Breno Bernardes-Souza  
  • Rayanna Mara De Oliveira Santos Pereira  
  • Roger Thomas  

  Abstract:

  Background: Most smokers start smoking during their early adolescence under the impression that smoking entails positive attributes. Given the addictive nature of cigarettes, however, many of them might end up as long-term smokers and suffering from tobacco-related diseases. To prevent tobacco use among adolescents, the large international medical students’ network Education Against Tobacco (EAT) educates more than 40,000 secondary school students per year in the classroom setting, using evidence-based self-developed apps and strategies. Objective: This study aimed to evaluate the long-term effectiveness of the school-based EAT intervention in reducing smoking prevalence among seventh-grade students in Germany. Additionally, we aimed to improve the intervention by drawing conclusions from our process evaluation. Methods: We conduct a cluster-randomized controlled trial with measurements at baseline and 9, 16, and 24 months postintervention via paper-and-pencil questionnaires administered by teachers. The study groups consist of randomized schools receiving the 2016 EAT curriculum and control schools with comparable baseline data (no intervention). The primary outcome is the difference of change in smoking prevalence between the intervention and control groups at the 24-month follow-up. Secondary outcomes are between-group differences of changes in smoking-related attitudes and the number of new smokers, quitters, and never-smokers. Results: A total of 11,268 students of both sexes, with an average age of 12.32 years, in seventh grade of 144 secondary schools in Germany were included at baseline. The prevalence of cigarette smoking in our sample was 2.6%. The process evaluation surveys were filled out by 324 medical student volunteers, 63 medical student supervisors, 4896 students, and 141 teachers. Conclusions: The EAT cluster randomized trial is the largest school-based tobacco-prevention study in Germany conducted to date. Its results will provide important insights with regards to the effectiveness of medical student–delivered smoking prevention programs at school. International Registered Report Identifier (IRRID): DERR1-10.2196/13508

  • JMIR Res Protoc 2019;8(4):e13508

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  Methods and Feasibility Studies

  Apr 10, 2019

  Socioeconomic Status and Racial or Ethnic Differences in Participation: Web-Based Survey

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  Authors List:

  • Myoungock Jang  
  • Allison Vorderstrasse  

  Abstract:

  Background: Web-based survey data collection has been widely used because of its advantages, although attaining and retaining participants can be challenging. There are several factors associated with successful Web-based survey participation; yet little is known regarding racial or ethnic and socioeconomic differences in the progress of a Web-based survey. Objective: This study aimed to examine racial or ethnic and socioeconomic status (SES) differences in participation in a Web-based survey. Methods: We conducted a secondary data analysis of a study dataset containing information on parents of preschool children. We used 2 phases of Web-based surveys: (1) screening questions including race or ethnicity information and (2) full survey with a consent form. Once potential participants submitted the screening questions, including their racial or ethnic information, the team sent the full survey link to potential participants who met study eligibility criteria. We calculated the proportion of racial or ethnic groups in each of the following areas: consent, partial survey completion, and total survey completion. Results: A total of 487 participants (236 non-Hispanic white, 44 Hispanic, 137 black, and 70 Asian) completed initial screening questions, and a total of 458 participants met study eligibility criteria. Compared with black participants, non-Hispanic white and Asian participants were more likely to consent to participate in the study (odds ratio [OR] 1.73, 95% CI 1.08-2.78, P=.02; OR 2.07, 95% CI 1.04-4.13, P=.04, respectively). There was no racial or ethnic difference with respect to the completion of demographic questions or completion of a partial survey. Finally, compared with black participants, non-Hispanic white participants were more likely to complete the entire survey (OR 3.36, 95% CI 1.51-7.06, P<.001). With respect to SES, less educated non-Hispanic white participants were less likely to complete the survey compared with their counterparts with more education (OR 0.15, 95% CI 0.50-1.48, P<.001). Conclusions: We found a significant difference among racial or ethnic groups as well as different education levels in Web-based survey participation. Survey researchers need to consider the SES and racial or ethnic differences in Web-based survey participation and develop strategies to address this bias in participation and completion in their research.

  • JMIR Res Protoc 2019;8(4):e11865

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  Non-randomized Protocols and Methods...

  Apr 9, 2019

  Hospital in Motion, a Multidimensional Implementation Project to Improve Patients’ Physical Behavior During Hospitalization: Protocol for a Mixed-Methods...

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  Authors List:

  • Lotte Martine Maria van Delft  
  • Petra Bor  
  • Karin Valkenet  
  • Cindy Veenhof  

  Abstract:

  Background: Despite the evidence of the adverse consequences of immobility during hospitalization, patients spend most of the time in bed. Although physical activity is a modifiable factor that can prevent in-hospital functional decline, bed rest is deeply rooted in the hospital culture. To attack this, a multidimensional approach is needed. Therefore, Hospital in Motion, a multidimensional implementation project, was designed to improve physical behavior during hospitalization. Objective: The primary objective of this study is to investigate the effectiveness of Hospital in Motion on inpatient physical behavior. Secondary objectives are to investigate the effectiveness on length of hospital stay and immobility-related complications of patients during hospitalization and to monitor the implementation process. Methods: For this study, Hospital in Motion will be implemented within 4 wards (cardiology, cardiothoracic surgery, medical oncology, and hematology) in a Dutch University Medical Center. Per ward, multidisciplinary teams will be composed who follow a step-by-step multidimensional implementation approach including the development and implementation of tailored action plans with multiple interventions to stimulate physical activity in daily care. A prepost observational study design will be used to evaluate the difference in physical behavior before and 1 year after the start of the project, including 40 patients per time point per ward (160 patients in total). The primary outcome measure is the percentage of time spent lying, measured with the behavioral mapping method. In addition, a process evaluation will be performed per ward using caregivers’ and patient surveys and semistructured interviews with patients and caregivers. Results: This study is ongoing. The first participant was enrolled in October 2017 for the premeasurement. The postmeasurements are planned for the end of 2018. The first results are expected to be submitted for publication in autumn 2019. Conclusions: This study will provide information about the effectiveness of the Hospital in Motion project on physical behavior and about the procedures of the followed implementation process aimed to incorporate physical activity in usual care. These insights will be useful for others interested in changing physical behavior during hospitalization. Trial Registration: Netherlands Trial Register NTR7109; https://www.trialregister.nl/trial/6914 (Archived by WebCite at http://www.webcitation.org/76dyhdjdd) International Registered Report Identifier (IRRID): DERR1-10.2196/11341

  • JMIR Res Protoc 2019;8(4):e11341

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  Non-randomized Protocols and Methods...

  Apr 9, 2019

  The Future of Health Care: Protocol for Measuring the Potential of Task Automation Grounded in the National Health Service Primary Care System

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  Authors List:

  • Matthew Willis  
  • Paul Duckworth  
  • Angela Coulter  
  • Eric T Meyer  
  • Michael Osborne  

  Abstract:

  Background: Recent advances in technology have reopened an old debate on which sectors will be most affected by automation. This debate is ill served by the current lack of detailed data on the exact capabilities of new machines and how they are influencing work. Although recent debates about the future of jobs have focused on whether they are at risk of automation, our research focuses on a more fine-grained and transparent method to model task automation and specifically focus on the domain of primary health care. Objective: This protocol describes a new wave of intelligent automation, focusing on the specific pressures faced by primary care within the National Health Service (NHS) in England. These pressures include staff shortages, increased service demand, and reduced budgets. A critical part of the problem we propose to address is a formal framework for measuring automation, which is lacking in the literature. The health care domain offers a further challenge in measuring automation because of a general lack of detailed, health care–specific occupation and task observational data to provide good insights on this misunderstood topic. Methods: This project utilizes a multimethod research design comprising two phases: a qualitative observational phase and a quantitative data analysis phase; each phase addresses one of the two project aims. Our first aim is to address the lack of task data by collecting high-quality, detailed task-specific data from UK primary health care practices. This phase employs ethnography, observation, interviews, document collection, and focus groups. The second aim is to propose a formal machine learning approach for probabilistic inference of task- and occupation-level automation to gain valuable insights. Sensitivity analysis is then used to present the occupational attributes that increase/decrease automatability most, which is vital for establishing effective training and staffing policy. Results: Our detailed fieldwork includes observing and documenting 16 unique occupations and performing over 130 tasks across six primary care centers. Preliminary results on the current state of automation and the potential for further automation in primary care are discussed. Our initial findings are that tasks are often shared amongst staff and can include convoluted workflows that often vary between practices. The single most used technology in primary health care is the desktop computer. In addition, we have conducted a large-scale survey of over 156 machine learning and robotics experts to assess what tasks are susceptible to automation, given the state-of-the-art technology available today. Further results and detailed analysis will be published toward the end of the project in early 2019. Conclusions: We believe our analysis will identify many tasks currently performed manually within primary care that can be automated using currently available technology. Given the proper implementation of such automating technologies, we expect considerable staff resources to be saved, alleviating some pressures on the NHS primary care staff. International Registered Report Identifier (IRRID): DERR1-10.2196/11232

  • JMIR Res Protoc 2019;8(4):e11232

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  RCTs - Protocols/Proposals (eHealth)

  Apr 8, 2019

  Person-Centered Interactive Self-Management Support in Primary Health Care for People with Type 2 Diabetes: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Ulrika Öberg  
  • Ulf Isaksson  
  • Lena Jutterström  
  • Carljohan Orre  
  • Åsa Hörnsten  

  Abstract:

  Background: Type 2 diabetes (T2D) is increasing as the population ages. The development of new medical treatments is promising and important, but the basic treatment remains self-management, even if adherence to lifestyle advice is low. Electronic health (eHealth) or mHealth interventions can increase empowerment among people living with T2D and may compensate for the lack of professional resources and geographical distances. The interactive self-management support (iSMS) project aims at including digital tools to support people living with T2D in their self-management and facilitating their interaction with diabetes specialist nurses (DSNs). This protocol outlines a study with the purpose of developing and evaluating an intervention where people living with T2D can increase self-efficacy and empowerment through digital self-monitoring and interaction with DSNs. Objective: To develop and evaluate a person-centered iSMS intervention in primary health care for people with T2D in addition to their usual diabetes care. Methods: This study is a 12-month, 3-armed, nonblinded randomized controlled trial (RCT), which will be conducted in 6 primary health care centers (HCCs) in northern Sweden. Eligible participants will be randomized to either an intervention group (n=46), a control group (n=46), or an external group (n=46) for comparison. The intervention group will receive the mobile app, and the control group will receive a minimal intervention (diabetes brochure) and the usual standard of care. Changes in glycated hemoglobin (HbA1c) will be the primary outcome measure. Results: This trial is currently open for recruitment. The first results are expected to be submitted for publication in Autumn 2019. Conclusions: This study, with its focus on iSMS, will provide insights regarding suitable ways to promote and develop a person-centered intervention. If successful, the intervention has the potential to become a model for the provision of self-management support to people with T2D.

  • JMIR Res Protoc 2019;8(4):e10250

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