JMIR Publications

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  Theme Issue (2018): Adolescent...

  Dec 14, 2018

  Development of an Electronic Data Collection System to Support a Large-Scale HIV Behavioral Intervention Trial: Protocol for an Electronic Data Collection...

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  Authors List:

  • W Scott Comulada  
  • Wenze Tang  
  • Dallas Swendeman  
  • Amy Cooper  
  • Jeremy Wacksman  
  • Adolescent Medicine Trials Network (ATN) CARES Team

  Abstract:

  Background: Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances for electronic data capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants, deliver intervention directly to participants’ mobile devices, monitor staff activity, and facilitate near real-time decision making during study implementation. Objective: This paper presents the infrastructure of an EDC system designed to support a multisite HIV biobehavioral intervention trial in Los Angeles and New Orleans: the Adolescent Medicine Trials Network “Comprehensive Adolescent Research & Engagement Studies” (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. Methods: The CARES EDC system is designed to monitor and document multiple study functions, including, screening, recruitment, retention, intervention delivery, and outcome assessment. Text messaging (short message service, SMS) and nearly all data collection are supported by the EDC system. The system functions on mobile phones, tablets, and Web browsers. Results: ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. Besides data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality, and field staff supervision. The system is supporting both incoming and outgoing text messages (SMS) and offers high-level data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using EDC systems are addressed through programming updates and training on how to improve data quality. Conclusions: There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided whether the flexibility provided by the development of a study-specific, in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, text messaging (SMS) interventions, and case management and a separate Web-based platform to support an online peer support intervention. Decisions need to be made regarding the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering text messages (SMS) to study participants’ mobile phones. EDC data security protocols should be developed under guidance from security experts and with formative consulting with the target study population as to their perceptions and needs. International Registered Report Identifier (IRRID): PRR1-10.2196/10777

  • JMIR Res Protoc 2018;7(12):e10777

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  Non-randomized Protocols and Methods...

  Dec 14, 2018

  Predicting Prediabetes Through Facebook Postings: Protocol for a Mixed-Methods Study

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  Authors List:

  • Xiaomeng Xu  
  • Michelle L Litchman  
  • Perry M Gee  
  • Webb Whatcott  
  • Loni Chacon  
  • John Holmes  
  • Sankara Subramanian Srinivasan  

  Abstract:

  Background: The field of infodemiology uses health care trends found in public networks, such as social media, to track and quantify the spread of disease. Type 2 diabetes is on the rise worldwide, and social media may be useful in identifying prediabetes through behavior exhibited through social media platforms such as Facebook and thus in designing and administering early interventions and containing further progression of the disease. Objective: This pilot study is designed to investigate the social media behavior of individuals with prediabetes, before and after diagnosis. Pre- and postdiagnosis Facebook content (posts) of such individuals will be used to create a taxonomy of prediabetes indicators and to identify themes and factors associated with an actual diagnosis of prediabetes. Methods: This is a single-center exploratory retrospective study that examines 20 adults with prediabetes. The investigators will code Facebook posts 3 months before through 3 months after prediabetes diagnosis. Data will be analyzed using both qualitative content analysis methodology as well as quantitative methodology to characterize participants and compare their posts pre- and postdiagnosis. Results: The project was funded for 2015-2018, and enrollment will be completed by the end of 2018. Data coding is currently under way and the first results are expected to be submitted for publication in 2019. Results will include both quantitative and qualitative data about participants and the similarities and differences between coded social media posts. Conclusions: This pilot study is the first step in creating a taxonomy of social media indicators for prediabetes. Such a taxonomy would provide a tool for researchers and health care professionals to use social media postings for identifying those at greater risk of having prediabetes. International Registered Report Identifier (IRRID): DERR1-10.2196/10720

  • JMIR Res Protoc 2018;7(12):e10720

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  Formative Studies and eHealth/mHealth...

  Dec 13, 2018

  Facilitating Web-Based Collaboration in Evidence Synthesis (TaskExchange): Development and Analysis

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  Authors List:

  • Tari Turner  
  • Emily Steele  
  • Chris Mavergames  
  • Julian Elliott  
  • Project Transform Team

  Abstract:

  Background: The conduct and publication of scientific research are increasingly open and collaborative. There is growing interest in Web-based platforms that can effectively enable global, multidisciplinary scientific teams and foster networks of scientists in areas of shared research interest. Designed to facilitate Web-based collaboration in research evidence synthesis, TaskExchange highlights the potential of these kinds of platforms. Objective: This paper describes the development, growth, and future of TaskExchange, a Web-based platform facilitating collaboration in research evidence synthesis. Methods: The original purpose of TaskExchange was to create a platform that connected people who needed help with their Cochrane systematic reviews (rigorous syntheses of health research) with people who had the time and expertise to help. The scope of TaskExchange has now been expanded to include other evidence synthesis tasks, including guideline development. The development of TaskExchange was initially undertaken in 5 agile development phases with substantial user engagement. In each phase, software was iteratively deployed as it was developed and tested, enabling close cycles of development and refinement. Results: TaskExchange enables users to browse and search tasks and members by keyword or nested filters, post and respond to tasks, sign up to notification emails, and acknowledge the work of TaskExchange members. The pilot platform has been open access since August 2016, has over 2300 members, and has hosted more than 630 tasks, covering a wide range of research synthesis-related tasks. Response rates are consistently over 75%, and user feedback has been positive. Conclusions: TaskExchange demonstrates the potential for new technologies to support Web-based collaboration in health research. Development of a relatively simple platform for peer-to-peer exchange has provided opportunities for systematic reviewers to get their reviews completed more quickly and provides an effective pathway for people to join the global health evidence community.

  • JMIR Res Protoc 2018;7(12):e188

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  Non-randomized Protocols and Methods...

  Dec 13, 2018

  Supported Web-Based Guided Self-Help for Insomnia for Young People Attending Child and Adolescent Mental Health Services: Protocol for a Feasibility Assessment

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  Authors List:

  • Bethany Cliffe  
  • Abigail Croker  
  • Megan Denne  
  • Paul Stallard  

  Abstract:

  Background: Sleep disturbance in adolescents is common, with up to one-third reporting significant symptoms of insomnia. Research with adults has demonstrated that Web-based cognitive behavioral therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking, and we know little about whether CBTi would have similar effects on this younger population. Objective: This paper summarizes the protocol of a study to assess the feasibility of adding supported Web-based CBTi to the usual care of young people aged 14-17 years attending specialist Child and Adolescent Mental Health Services (CAMHS). Methods: This is an open trial where we will recruit young people (N=50) aged 14-17 years attending specialist CAMHS with primary or comorbid symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6-session, Web-based CBTi self-help program for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction, and cognitive techniques that participants will be helped to apply through brief, weekly telephone support calls. Questionnaires and interviews will be completed at baseline and postintervention (8-10 weeks) and will assess sleep, symptoms of depression and anxiety, and acceptability of Sleepio and telephone support. Results: Recruitment started in May 2018 and continued until the end of October 2018. Conclusions: This study will provide preliminary evidence about whether supported Web-based CBTi is acceptable to young people with mental health problems and about the postintervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomized trial to determine the effectiveness of Sleepio should be undertaken. International Registered Report Identifier (IRRID): DRR1-10.2196/11324

  • JMIR Res Protoc 2018;7(12):e11324

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  Non-Randomized Studies (funded,...

  Dec 13, 2018

  Benefits of Elective Para-Aortic Radiotherapy for pN1 Prostate Cancer Using Arc Therapy (Intensity-Modulated or Volumetric Modulated Arc Therapy): Protocol...

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  Authors List:

  • Cédric Draulans  
  • Steven Joniau  
  • Valérie Fonteyne  
  • Louke Delrue  
  • Karel Decaestecker  
  • Wouter Everaerts  
  • Piet Dirix  
  • Laura Van den Bergh  
  • Wouter Crijns  
  • Hans Vandendriessche  
  • Lodewijk Van Wynsberge  
  • Piet Ost  
  • Nicolaas Lumen  
  • Pieterjan Buelens  
  • Karin Haustermans  
  • Charlien Berghen  
  • Gert De Meerleer  

  Abstract:

  Background: In patients with prostate cancer (PCa) with histopathologically proven pelvic lymph node (LN) metastasis (pN1) after extended pelvic lymph node dissection (ePLND), multimodality treatment consisting of treatment of the primary tumor and whole pelvic radiotherapy (WPRT) combined with androgen deprivation therapy (ADT) offers promising results, leading to better cause-specific survival rates compared with ADT alone. However, in case more than one pelvic LN is invaded by the tumor, approximately 40% of the patients relapse biochemically and clinically. Clinical relapse is present in the para-aortic LNs (M1a disease) in up to 77% of the relapsing cases. Objective: We hypothesize that, based on the evidence that positive LNs represent the door to hematogenous dissemination, elective para-aortic irradiation will reduce the development of both retroperitoneal nodal (M1a) and distant metastasis (M1b or M1c disease), postpone the need for palliative ADT, and prolong the time to castration-refractory disease. Methods: To test this hypothesis, we will conduct a prospective, nonrandomized phase II trial to study the efficacy of additional elective para-aortic radiotherapy (PART) in pN1 patients compared with those who were historically treated with adjuvant WPRT alone. We aim to include 137 patients with PCa and presence of pN1 disease after ePLND. With this number of patients, an improvement of 15% in the 5-year clinical relapse-free survival can be detected with a power of 80%. Results: Recruitment of patients for this trial started in 2017 and will be completed approximately by March 2020. Conclusions: This is the first phase II trial to investigate the benefits of an elective PART in patients with PCa. The results of this trial will potentially serve as a sound base for a later randomized phase III trial. All participants are given a PART information sheet and required to give written informed consent. Results are expected to be published in a peer-reviewed journal. Trial Registration: ClinicalTrials.gov NCT03079323; https://clinicaltrials.gov/ct2/show/NCT03079323 (Archived by WebCite at http://www.webcitation.org/73ELimv1d) International Registered Report Identifier (IRRID): PRR1-10.2196/11256

  • JMIR Res Protoc 2018;7(12):e11256

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  Non-randomized Protocols and Methods...

  Dec 10, 2018

  Development and Validation of a Diabetic Retinopathy Screening Modality Using a Hand-Held Nonmydriatic Digital Retinal Camera by Physician Graders at a...

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  Authors List:

  • Mapa Mudiyanselage Prabhath Nishantha Piyasena  
  • Venkata S. Murthy Gudlavalleti  
  • Clare Gilbert  
  • Jennifer LY Yip  
  • Tunde Peto  
  • David MacLeod  
  • Charith Fonseka  
  • Aruna Kulatunga  
  • B.G.W.M.K.C.B. Bandutilake  
  • Mangala Dhanapala  
  • Lalani Pathirana  
  • Heshani Dissanayake  

  Abstract:

  Background: Visual impairment and blindness from diabetic retinopathy (DR), which can be reduced by early screening and treatment, is an emerging public health concern in low-income and middle-income countries (LMICs) owing to the increasing prevalence of diabetes mellitus (DM). However, no systematic screening exists in most LMIC settings. The Western province of Sri Lanka has the highest prevalence of DM (18.6%) in the country. A situational analysis identified a marked gap in DR screening (DRS) and treatment services uptake in this region; only opportunistic screening is practiced currently. Objective: The aim of this protocol is to describe the methods of development and validation of a DRS intervention using a hand-held nonmydriatic digital camera by physician graders in a non-ophthalmological setting at a tertiary-level medical clinic to propose a valid and feasible modality to improve uptake. Methods: DRS modality was developed after assessing barriers and identifying the most appropriate personnel, methods, and location for screening services, following formative research work. The validation will be conducted in a public sector tertiary care center in the Western province of Sri Lanka. The selected physicians will be trained on capturing and grading images according to a valid locally adopted protocol. Two physicians rated high on training will screen a sample of 506 people with DM at a medical clinic. They will use nonmydriatic and mydriatic 2-field imaging strategy. The validity of the proposed screening procedure will be assessed and compared with the mydriatic indirect biomicroscopic examination by a senior retinologist. Results: The validity of screening by physician graders will be analyzed and the sensitivity, specificity, and predictive values (with 95% CIs) calculated by the dilation status and for each grader. The diagnostic accuracy at each level of severity of DR will be assessed to define the most appropriate referable criteria. Data is currently being collected. Conclusions: The outcome of this study will be useful for the detection of a defined level of DR at non-ophthalmological setting to filter the people with DM before referral to an eye clinic. This will be helpful to improve the uptake and identify risk groups in advance to prevent sight-threatening DR. Furthermore, evidence from this study will be useful for the implementation of a DRS program in this region and in similar communities. International Registered Report Identifier (IRRID): PRR1-10.2196/10900

  • JMIR Res Protoc 2018;7(12):e10900

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  Non-randomized Protocols and Methods...

  Dec 10, 2018

  Establishing Digital Biomarkers for Occupational Health Assessment in Commercial Salmon Fishermen: Protocol for a Mixed-Methods Study

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  Authors List:

  • Rachel Elizabeth Wilbur  
  • Jacob Spencer Griffin  
  • Mark Sorensen  
  • Robert Daniel Furberg  

  Abstract:

  Background: Commercial salmon fishing in Alaska is one of the most dangerous occupations in the United States. Between 1992 and 2008, the average annual industry mortality rate was 128 deaths per 100,000 workers, and despite an increase in industry regulations, there has not been a significant decrease in mortality rate since 2000. Unpredictable fishing openings and fierce competition for limited resources result in periods of intense sleep deprivation and physical strain during the short commercial salmon season in Alaska. Objective: We hypothesize that the combined effect of sleep deprivation, intense physical workload, and significant short-term chronic stress may be deleterious to health in both the short- and long-term among commercial salmon drift gillnet fishermen in Alaska. The objective of this protocol is to determine the feasibility of the study design to test this hypothesis. Methods: The study design uses mixed methods and includes biometric monitoring consisting of heart rate variability, respiration, and movement data collected via a personal, wearable biometric device. Additional methods include observational data on activity, including duration and quality of sleep, weather, catch, and financial gain, as well as the collection of salivary cortisol. As such, the study will provide a holistic assessment of individual stress on multiple simultaneous timescales: immediately and continuously through the personal wearable biometric device, on the minute-hour level through the multiple daily collections of salivary cortisol, and by the hour-day through the use of participant and environment observational data. Results: Data collection was initiated in July 2017 and will extend through August 2019. Initial data collection has indicated that the methods outlined in this protocol are feasible and allow for effective collection of qualitative and quantitative data related to the psychological and physiological impact of Alaska commercial salmon fishing. Conclusions: We anticipate that the use of a biometric device will be crucial in establishing measures of stress and physical activity within a population and environment uniquely challenged by physical isolation, strong weather patterns, and the potential for significant financial gain by fishermen. The potential exists for individuals engaged long-term in the fishing industry, through repeated and extended exposure to periods of intense sleep deprivation and chronic stress, to be at increased risk of cardiovascular disease. International Registered Report Identifier (IRRID): DERR1-10.2196/10215

  • JMIR Res Protoc 2018;7(12):e10215

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  RCTs - Protocols/Proposals (funded,...

  Dec 7, 2018

  A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial...

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  Authors List:

  • Michael P Dorsch  
  • Lawrence C An  
  • Scott L Hummel  

  Abstract:

  Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. Trial Registration: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) International Registered Report Identifier (IRRID): PRR1-10.2196/11282

  • JMIR Res Protoc 2018;7(12):e11282

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  NHS funded proposals with peer-review...

  Dec 7, 2018

  An Electronic Clinical Decision Support System for the Assessment and Management of Suicidality in Primary Care: Protocol for a Mixed-Methods Study

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  Authors List:

  • Matthew Horrocks  
  • Maria Michail  
  • Aimee Aubeeluck  
  • Nicola Wright  
  • Richard Morriss  

  Abstract:

  Background: Suicide is a global public health concern, but it is preventable. Increased contact with primary care before the suicide or attempted suicide raises opportunities for intervention and prevention. However, suicide assessment and management are areas that many general practitioners (GPs) find particularly challenging. Previous research has indicated significant variability in how GPs understand, operationalize, and assess suicide risk, which subsequently has an impact on clinical decision making. Clinical decision support systems (CDSS) have been widely implemented across different health care settings, including primary care to support practitioners in clinical decision making. A CDSS may reduce inconsistencies in the identification, assessment, and management of suicide risk by GPs by guiding them through the consultation and generating a risk assessment plan that can be shared with a service user or with specialized mental health services. Objective: Our aim is to co-develop and test with end users (eg, GPs, primary care attendees, mental health professionals) an electronic clinical decision support system (e-CDSS) to support GPs in the identification, assessment, and management of suicidality in primary care. Methods: Ours is an ongoing embedded mixed-methods study with four phases: (1) qualitative interviews with GPs to explore their views on the content, format, and use of the e-CDSS, as well as consultation with two service-user advisory groups (people aged ≤25 and people aged ≥25) to inform the content of the e-CDSS including phrasing of items and clarity; (2) participatory co-production workshops with GPs, service users, and clinical experts in suicidality to determine the content and format of the e-CDDS; gain consensus of the relevance of items; establish content validity and identify pathways to implementation, using the Consolidated Framework for Implementation Research; (3) building the e-CDSS so that it guides the GP through a consultation; and (4) usability testing of the e-CDSS with GPs and service users in one primary care practice involving a nonlive and a live stage. Results: The study was funded for four years, to take place between 2015 and 2019, and is currently completing phase 4 data collection. The first results are expected to be submitted for publication in June 2019. The findings will enable us to evaluate the feasibility, acceptability, and usability of a suicide-specific, electronic, guided decision support system in primary care. Conclusions: This study will be the first to explore the feasibility, acceptability, and usability of an electronic, guided decision support system for use in primary care consultations for the improved assessment and management of suicidality. International Registered Report Identifier (IRRID): RR1-10.2196/11135

  • JMIR Res Protoc 2018;7(12):e11135

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  Non-Randomized Study Protocols and...

  Dec 7, 2018

  Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study

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  Authors List:

  • Nathan Smischney  
  • Rahul Kashyap  
  • Mohamed Seisa  
  • Darrell Schroeder  
  • Daniel Diedrich  

  Abstract:

  Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation occurs, the current practice is largely unknown. This is relevant, as advances in airway equipment (ie, video laryngoscopes) have become more prevalent, leading to possible improvement of care delivered during this process. In addition to new devices, a greater emphasis on airway plans and choices in sedation have evolved, although the influence on patient morbidity and mortality is largely unknown. Objective: This study aims to derive and validate prediction models for immediate airway and hemodynamic complications of intensive care unit intubations. Methods: A multicenter, observational, prospective study of adult critically ill patients admitted to both medical and surgical intensive care units (ICUs) was conducted. Participating ICU sites were located throughout eight health and human services regions of the United States for which endotracheal intubation was needed. A steering committee composed of both anesthesia and pulmonary critical care physicians proposed a core set of data variables. These variables were incorporated into a data collection form to be used within the multiple, participating ICUs across the United States during the time of intubation. The data collection form consisted of two basic components, focusing on airway management and hemodynamic management. The form was generated using RedCap and distributed to the participating centers. Quality checks on the dataset were performed several times with each center, such that they arrived at less than 10% missing values for each data variable; the checks were subsequently entered into a database. Results: The study is currently undergoing data analysis. Results are expected in November 2018 with publication to follow thereafter. The study protocol has not yet undergone peer review by a funding body. Conclusions: The overall goal of this multicenter prospective study is to develop a scoring system for peri-intubation, hemodynamic, and airway-related complications so we can stratify those patients at greatest risk for decompensation as a result of these complications. This will allow critical care physicians to be better prepared in addressing these occurrences and will allow them to improve the quality of care delivered to the critically ill. Trial Registration: ClinicalTrials.gov NCT02508948; https://clinicaltrials.gov/ct2/show/NCT02508948 (Archived by WebCite at http://www.webcitation.org/73Oj6cTFu) International Registered Report Identifier (IRRID): RR1-10.2196/11101

  • JMIR Res Protoc 2018;7(12):e11101

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  RCTs - Protocols/Proposals (funded,...

  Dec 6, 2018

  Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Francisco Jódar-Sánchez  
  • Laura Carrasco Hernández  
  • Francisco J Núñez-Benjumea  
  • Marco Antonio Mesa González  
  • Jesús Moreno Conde  
  • Carlos Luis Parra Calderón  
  • Luis Fernandez-Luque  
  • Santiago Hors-Fraile  
  • Anton Civit  
  • Panagiotis Bamidis  
  • Francisco Ortega-Ruiz  

  Abstract:

  Background: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). Methods: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. Results: Of 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. Conclusions: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). International Registered Report Identifier (IRRID): PRR1-10.2196/12464

  • JMIR Res Protoc 2018;7(12):e12464

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  RCTs - Protocols/Proposals (funded,...

  Dec 6, 2018

  Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic...

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  Authors List:

  • Katsuhiro Mizuno  
  • Takayuki Abe  
  • Junichi Ushiba  
  • Michiyuki Kawakami  
  • Tomomi Ohwa  
  • Kazuto Hagimura  
  • Miho Ogura  
  • Kohei Okuyama  
  • Toshiyuki Fujiwara  
  • Meigen Liu  

  Abstract:

  Background: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. Objective: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. Methods: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. Results: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. Conclusions: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. Trial Registration: UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) International Registered Report Identifier (IRRID): DERR1-10.2196/12339

  • JMIR Res Protoc 2018;7(12):e12339

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