JMIR Publications

Recent Articles:

• 

  RCTs - Protocols/Proposals (funded,...

  Oct 23, 2018

  Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized...

  View Authors View Abstract

  Authors List:

  • Ana-Maria Vranceanu  
  • Emily L Zale  
  • Christopher J Funes  
  • Eric A Macklin  
  • Jessica McCurley  
  • Elyse R Park  
  • Justin T Jordan  
  • Ann Lin  
  • Scott R Plotkin  

  Abstract:

  Background: Neurofibromatoses (NF) are rare genetic conditions associated with substantial psychosocial burden and impaired quality of life (QoL). We developed the first NF-tailored mind-body program (the Relaxation Response Resiliency Program for NF) and adapted it for delivery via live videoconferencing to decrease participation barriers and increase its reach. In a pilot randomized controlled trial (RCT), we found that the Relaxation Response Resiliency Program for NF had excellent feasibility and acceptability when delivered via live videoconferencing; furthermore, the Relaxation Response Resiliency Program for NF showed proof of concept in improving QoL compared with an NF-tailored health education control program (the Health Enhancement Program for NF). A fully powered trial is needed to ascertain the efficacy and durability of the Relaxation Response Resiliency Program for NF delivered via secure live videoconferencing among geographically diverse patients. Objective: The objective of this study is to evaluate the efficacy of the Relaxation Response Resiliency Program for NF versus the Health Enhancement Program for NF, both delivered in groups via secure live videoconferencing, among geographically diverse patients with NF across the United States and internationally. Here we describe the protocol, manualized treatments, evaluation plan, and study design. Methods: This is a single-blind RCT. Patients are told that they will be randomized to one of the two stress management programs (stress management program 1: the Relaxation Response Resiliency Program for NF and stress management program 2: the Health Enhancement Program for NF). Patients are recruited from NF-specific national and international foundations and NF clinics across the United States through study ads and a video of participants who have completed the program as part of the pilot study or ongoing trial. Interested participants are screened for eligibility via secure live videoconferencing (self-reported stress and difficulties coping, no change in antidepressant medication within the past 3 months, no psychotherapy within the past 3 months, no major upcoming surgeries within the next 12 months, English speaking, and able to complete questionnaires online and participate in live video interventions) and consent obtained before participation. Both programs are manualized comprising 8 sessions delivered via secure live videoconferencing by trained clinical psychologists. Primary outcomes are physical health QoL and psychological health QoL. Secondary outcomes are social relationship QoL, environment QoL, and psychosocial and resiliency variables. Outcomes are assessed at baseline, posttraining, and 6- and 12-month follow-ups. Results: The trial is ongoing. Thus far, we have recruited 55 patients and aim to recruit a total of 224. Recruitment will close in May 2020; we plan to complete data analyses by June 2021. Conclusions: This trial will answer key questions about the efficacy and durability of the Relaxation Response Resiliency Program for NF via live videoconferencing with English-speaking adults with NF worldwide. If found efficacious, this program can be readily implemented through national and international NF foundations and NF-specific clinics. The virtual model of delivery has extensive applications for patients in rural areas, those with disability or illness that precludes travel to clinics, and those with rare diseases. Trial Registration: ClinicalTrials.gov NCT03406208; https://clinicaltrials.gov/ct2/show/NCT03406208 (Archived by WebCite at http://www.webcitation.org/72ZoTDQ6h) International Registered Report Identifier (IRRID): RR1-10.2196/11008

  • JMIR Res Protoc 2018;7(10):e11008

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Oct 22, 2018

  Unraveling the Biopsychosocial Factors of Fatigue and Sleep Problems After Traumatic Brain Injury: Protocol for a Multicenter Longitudinal Cohort Study

  View Authors View Abstract

  Authors List:

  • Jessica Bruijel  
  • Sven Z Stapert  
  • Annemiek Vermeeren  
  • Jennie L Ponsford  
  • Caroline M van Heugten  

  Abstract:

  Background: Fatigue and sleep problems are common after a traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory, and they can drastically impact the quality of life and societal participation of the patient and their family and friends. However, the etiology and development of these symptoms are still uncertain. Objective: The aim of this study is to examine the development of fatigue and sleep problems following moderate to severe TBI and to explore the changes in underlying biological (pain, brain damage), psychological (emotional state), and social (support family, participation) factors across time. Methods: This study is a longitudinal multicenter observational cohort study with 4 measurement points (3, 6, 12, and 18 months postinjury) including subjective questionnaires and cognitive tasks, preceded by 7 nights of actigraphy combined with a sleep diary. Recruitment of 137 moderate to severe TBI patients presenting at emergency and neurology departments or rehabilitation centers across the Netherlands is anticipated. The evolution of fatigue and sleep problems following TBI and their association with possible underlying biological (pain, brain damage), psychological (emotional state), and social (support family, participation) factors will be examined. Results: Recruitment of participants for this longitudinal cohort study started in October 2017, and the enrollment of participants is ongoing. The first results are expected at the end of 2020. Conclusions: To the authors’ knowledge, this is the first study that examines the development of both post-TBI fatigue and sleep longitudinally within a biopsychosocial model in moderate to severe TBI using both subjective and objective measures. Identification of modifiable factors such as mood and psychosocial stressors may give direction to the development of interventions for fatigue and sleep problems post-TBI. Trial Registration: Netherlands Trial Register NTR7162; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7162 (Archived by WebCite at http://www.webcitation.org/6z3mvNLuy) International Registered Report Identifier (IRRID): RR1-10.2196/11295

  • JMIR Res Protoc 2018;7(10):e11295

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Oct 19, 2018

  The Clinical and Cost-Effectiveness of 4 Enzyme-Linked Immunosorbent Assay Kits for Monitoring Infliximab in Crohn Disease Patients: Protocol for a...

  View Authors View Abstract

  Authors List:

  • Thomas Langford  
  • Zehra Arkir  
  • Anastasia Chalkidou  
  • Kate Goddard  
  • Lamprini Kaftantzi  
  • Mark Samaan  
  • Peter Irving  

  Abstract:

  Background: Currently, treatment decisions for people with Crohn disease are based on clinical judgment and trial and error. Consequently, people may continue to receive high drug dosages and experience unnecessary toxicity when it is possible to reduce or discontinue without a detrimental effect on clinical outcomes. Therapeutic drug monitoring (TDM) involves regularly testing blood samples for drug and antibody levels that could help clinicians identify the optimal treatment strategy and pre-empt treatment failure. However, heterogeneity in the assays can lead to a discrepancy in results and difficulties in decision-making. Standardization of the kits, and therefore results, would allow clinicians to optimize the use of biologics. Currently, there is also a lack of evidence for the cost-effectiveness of TDM using commercial test kits. Objective: This study aims to analyze the clinical and cost-effectiveness of 4 commercial enzyme-linked immunosorbent assay (ELISA) kits (LISA TRACKER, IDKmonitor, Promonitor, and RIDASCREEN) to generate evidence which could support a recommendation for wider adoption in the National Health Service. Methods: We propose to carry out a prospective-retrospective predictive biomarker validation study using the blood samples and clinical/utilization data collected during the ongoing SPARE trial (NCT02177071). A total of 200 stored samples from people with Crohn's disease who respond to treatment with infliximab will be used along with clinical and cost data from the trial. We will investigate the relationship between the drug and antidrug antibody levels with the main clinical outcomes (relapse rate at 2 years and time spent in remission), as well as resource utilization and quality of life. Results: Funding is being sought to conduct this research. Conclusions: This is the first study to compare the 4 ELISA kits for monitoring infliximab in patients with Crohn disease. It aims to address the uncertainties in the potential benefits of using the technologies for TDM. International Registered Report Identifier (IRRID): PRR1-10.2196/11218

  • JMIR Res Protoc 2018;7(10):e11218

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Oct 19, 2018

  Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Olveen Carrasquillo  
  • BreAnne Young  
  • Stuti Dang  
  • Orieta Fontan  
  • Natalie Ferras  
  • Jose G Romano  
  • Chuanhui Dong  
  • Sonjia Kenya  

  Abstract:

  Background: Hispanic-Latino populations face a disproportionate stroke burden and are less likely to have sufficient control over stroke risk factors in comparison with other ethnic populations. A promising approach to improving chronic health outcomes has been the use of community health workers (CHWs). Objective: The objective of this randomized controlled trial is to evaluate the effectiveness of a CHW intervention among Latino patients at risk of recurrent stroke. Methods: The Hispanic Secondary Stroke Prevention Initiative (HiSSPI) is a randomized clinical trial of 300 Latino participants from South Florida who have experienced a stroke within the last 5 years. Participants randomized into the CHW intervention arm receive health education and assistance with health care navigation and social services through home visits and phone calls. The intervention also includes a mHealth component in which participants also receive daily text messages (short message service). The primary outcome is change in systolic blood pressure at 12 months. Other secondary outcomes include changes in low-density lipoprotein, glycated hemoglobin, and medication adherence. Results: Study enrollment began in 2015 and will be completed by the end of 2018. The first results are expected to be submitted for publication in 2020. Conclusions: HiSSPI is one of the first randomized controlled trials to examine CHW-facilitated stroke prevention and will provide rigorous evidence on the impact of CHWs on secondary stroke risk factors among Latino individuals who have had a stroke. Trial Registration: ClinicalTrials.gov NCT02251834; https://clinicaltrials.gov/ct2/show/NCT02251834 (Archived by WebCite at http://www.webcitation.org/72DgMqftq) International Registered Report Identifier (IRRID): RR1-10.2196/11083

  • JMIR Res Protoc 2018;7(10):e11083

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Oct 18, 2018

  Connectivity as a Predictor of Responsiveness to Transcranial Direct Current Stimulation in People with Stroke: Protocol for a Double-Blind Randomized...

  View Authors View Abstract

  Authors List:

  • Ellana Welsby  
  • Michael Ridding  
  • Susan Hillier  
  • Brenton Hordacre  

  Abstract:

  Background: Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological rehabilitation. One approach is to use noninvasive brain stimulation techniques, such as transcranial direct current stimulation, to induce a neuroplastic response. When delivered in combination with rehabilitation exercises, there is some evidence that transcranial direct current stimulation is beneficial. However, responses to stimulation are highly variable. Therefore biomarkers predictive of response to stimulation would be valuable to help select appropriate people for this potentially beneficial treatment. Objective: The objective of this study is to investigate connectivity of the stimulation target, the ipsilesional motor cortex, as a biomarker predictive of response to anodal transcranial direct current stimulation in people with stroke. Methods: This study is a double blind, randomized controlled trial (RCT), with two parallel groups. A total of 68 participants with first ever ischemic stroke with motor impairment will undertake a two week (14 session) treatment for upper limb function (Graded Repetitive Arm Supplementary Program; GRASP). Participants will be randomized 2:1 to active:sham treatment groups. Those in the active treatment group will receive anodal transcranial direct current stimulation to the ipsilesional motor cortex at the start of each GRASP session. Those allocated to the sham treatment group will receive sham transcranial direct current stimulation. Behavioural assessments of upper limb function will be performed at baseline, post treatment, 1 month follow-up and 3 months follow-up. Neurophysiological assessments will include magnetic resonance imaging (MRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) and will be performed at baseline, post treatment, 1 month follow-up (EEG and TMS only) and 3 months follow-up (EEG and TMS only). Results: Participants will be recruited between March 2018 and December 2018, with experimental testing concluding in March 2019. Conclusions: Identifying a biomarker predictive of response to transcranial direct current stimulation would greatly assist clinical utility of this novel treatment approach. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12618000443291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000443291 (Archived by WebCite at http://www.webcitation.org/737QOXXxt) Registered Report Identifier: RR1-10.2196/10848

  • JMIR Res Protoc 2018;7(10):e10848

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Oct 18, 2018

  Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Laurie Zawertailo  
  • Tara Mansoursadeghi-Gilan  
  • Helena Zhang  
  • Sarwar Hussain  
  • Bernard Le Foll  
  • Peter Selby  

  Abstract:

  Background: Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. Objective: The primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation. Methods: This is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales. Results: The project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway. Conclusions: To the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials. Trial Registration: ClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ) Registered Report Identifier: RR1-10.2196/10826

  • JMIR Res Protoc 2018;7(10):e10826

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Grant Proposals (eHealth, funded)

  Oct 17, 2018

  Facilitating the Informed Consent Process Using Teleconsent: Protocol for a Feasibility and Efficacy Study

  View Authors View Abstract

  Authors List:

  • Saif Khairat  
  • Paige Ottmar  
  • Betsy Sleath  
  • Brandon Welch  
  • Suparna Qanungo  
  • Michelle Nichols  
  • Jihad S. Obeid  

  Abstract:

  Background: Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants—particularly minorities and participants from rural communities. Objective: The objective of this study is to utilize telemedicine to improve the informed consent process for clinical trials and studies. We aim to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings. Methods: This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina and the University of North Carolina at Chapel Hill, to compare results within and across institutions. Results: Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018. Conclusions: In this paper, we present a novel approach for conducting informed consent using a new telemedicine modality, namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants. Registered Report Identifier: RR1-10.2196/11239

  • JMIR Res Protoc 2018;7(10):e11239

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Systematic Review Protocols

  Oct 16, 2018

  Gamified Cognitive Bias Interventions for Psychiatric Disorders: Protocol of a Systematic Review

  View Authors View Abstract

  Authors List:

  • Melvyn Zhang  
  • Jiangbo Ying  
  • Roger CM Ho  

  Abstract:

  Background: Cognitive bias modification has been increasingly studied in the past decade with reviews reporting the effectiveness of bias modification. Advances in electronic health and mobile health technologies have transformed how conventional cognitive bias modification is delivered. To date, gamification technologies and serious games have been widely evaluated in health care, and prior studies have reported the use of gamification for cognitive bias modification. However, no prior research, to date, has systematically evaluated the literature for gamified cognitive bias modification interventions. Objective: The proposed systematic review aims to review how gamification has been applied to cognitive bias modification interventions. Methods: A systematic review will be conducted. A search will be conducted on the respective databases till 2018. Selection of the studies will be determined by the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Quality assessment of the included studies will be assessed using the Cochrane Risk of Bias Tool. In addition, a narrative synthesis will be conducted. Results: We expect that the review will be completed 12 months from the publication of this protocol. Conclusions: The findings that arise from this review will be crucial as they will inform future research that seeks to integrate gamification technologies into existing conventional bias modification interventions. Registered Report Identifier: RR1-10.2196/10154

  • JMIR Res Protoc 2018;7(10):e10154

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-randomized Protocols and Methods...

  Oct 15, 2018

  Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial

  View Authors View Abstract

  Authors List:

  • Afef Ben Halima  
  • Sana Ouali  
  • Mohamed Sami Mourali  
  • Sonia Chabrak  
  • Rafik Chettaoui  
  • Manel Ben Halima  
  • Abdeddayem Haggui  
  • Noureddine Larbi  
  • Salma Krichène  
  • Sonia Marrakchi  
  • Slim Kacem  
  • Rim Chrigui  
  • Mohamed Fahmi Abbes  
  • Hédi Baccar  
  • Nadia Baraket  
  • Najeh Ben Halima  
  • Ali Ben Khalfallah  
  • Mohamed Ben Mbarek  
  • Soraya Ben Youssef  
  • Essia Boughzala  
  • Mohamed Rachid Boujnah  
  • Habiba Drissa  
  • Habib Gamra  
  • Ali Gasmi  
  • Habib Haouala  
  • Youssef Harrath  
  • Ines Issa  
  • Gouider Jeridi  
  • Salem Kachboura  
  • Samir Kammoun  
  • Sondes Kraiem  
  • Faouzi Maatouk  
  • Sami Milouchi  
  • Wided Nasraoui  
  • Ali Neji  
  • Khaled Sayahi  
  • Wissem Sdiri  
  • Wajih Smati  
  • Samir Tlili  
  • Leila Abid  
  • Salem Abdesselem  
  • Lilia Zakhama  
  • Abdallah Mahdhaoui  
  • Helmi Kammoun  
  • Skander Ben Omrane  
  • Faouzi Addad  

  Abstract:

  Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. Objective: The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. Methods: A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. Results: Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. Conclusions: This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. Trial Registration: ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX) Registered Report Identifier: RR1-10.2196/8523

  • JMIR Res Protoc 2018;7(10):e181

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Oct 15, 2018

  Mobile Phone Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Protocol and Baseline Overview for a Randomized...

  View Authors View Abstract

  Authors List:

  • Alexander V Prokhorov  
  • Georges Elias Khalil  
  • Karen Sue Calabro  
  • Tamara Costello Machado  
  • Sophia Russell  
  • Katarzyna W Czerniak  
  • Gabrielle C Botello  
  • Minxing Chen  
  • Adriana Perez  
  • Damon J Vidrine  
  • Cheryl L Perry  

  Abstract:

  Background: Community-college students are at high risk for tobacco use. Because the use of mobile phone text messaging is nearly ubiquitous today, short message service (SMS) may be an effective strategy for tobacco risk communication in this population. Little is known, however, concerning the message structure significantly influencing perceived tobacco risk. Objective: We aim to outline the rationale and design of Project Debunk, a randomized trial comparing the effects of different SMS text message structures. Methods: We conducted a 6-month randomized trial comparing 8 arms, based on the combination of the 3 message structures delivered to young adults in a 2×2×2 study design: framing (gain-framed or loss-framed), depth (simple or complex), and appeal (emotional or rational). Participants were invited to participate from 3 community colleges in Houston from September 2016 to July 2017. Participants were randomized to 1 arm and received text messages in 2 separate campaigns. Each campaign consisted of 2 text messages per day for 30 days. Perceived tobacco risk was assessed at baseline, 2 months after the first campaign, and 2 months after the second campaign. We assessed the perceived risk of using conventional products (eg, combustible cigarettes) and new and emerging products (eg, electronic cigarettes). The validity of message structures was assessed weekly for each campaign. A 1-week follow-up assessment was also conducted to understand immediate reactions from participants. Results: We completed data collection for the baseline survey on a rolling basis during this time and assessed the validity of the message structure after 1 week of SMS text messages. For the entire sample (N=636), the average age was 20.92 years (SD 2.52), about two-thirds were male (430/636, 67.6%), and most were black or African American (259/636, 40.7%) or white (236/636, 37.1%). After 1 week of receiving text messages, the following was noted: (a) loss-framed messages were more likely to be perceived as presenting a loss than gain-framed messages (F7,522=13.13, P<.001), (b) complex messages were perceived to be more complex than simple messages (F7,520=2.04, P=.05), and (c) emotional messages were perceived to be more emotionally involving than rational messages (F7,520=6.46, P<.001). Conclusions: This study confirms that the recruitment, randomization, and message composition have been successfully implemented. Further analyses will identify specific types of messages that are more effective than others in increasing the perceived risk of tobacco use. If our results suggest that any of the 8 specific message structures are more effective for helping young adults understand tobacco risk, this would provide evidence to include such messages as part of a larger technology-based campaign such as mobile phone apps, entertainment-based campaigns, and social media. Trial Registration: ClinicalTrials.gov NCT03457480; https://clinicaltrials.gov/ct2/show/NCT03457480 (Archived by WebCite at http://www.webcitation.org/6ykd4IIap) Registered Report Identifier: RR1-10.2196/10977

  • JMIR Res Protoc 2018;7(10):e10977

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Oct 12, 2018

  Development and Management of Networks of Care at the End of Life (the REDCUIDA Intervention): Protocol for a Nonrandomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Silvia Librada Flores  
  • Emilio Herrera Molina  
  • Fátima Díaz Díez  
  • María José Redondo Moralo  
  • Cristina Castillo Rodríguez  
  • Kathleen McLoughlin  
  • Julian Abel  
  • Tamen Jadad Garcia  
  • Miguel Ángel Lucas Díaz  
  • Inmaculada Trabado Lara  
  • María Dolores Guerra-Martín  
  • María Nabal  

  Abstract:

  Background: End-of-life needs can be only partly met by formalized health and palliative care resources. This creates the opportunity for the social support network of family and community to play a crucial role in this stage of life. Compassionate communities can be the missing piece to a complete care model at the end of life. Objective: The main objective of this study is to evaluate the REDCUIDA (Redes de Cuidados or Network of Care) intervention for the development and management of networks of care around people with advanced disease or at the end of life. Methods: The study is a 2-year nonrandomized controlled trial using 2 parallel groups. For the intervention group, we will combine palliative care treatment with a community promoter intervention, compared with a control group without intervention. Participants will be patients under a community palliative care team’s supervision with and without intervention. The community promotor will deliver the intervention in 7 sessions at 2 levels: the patient and family level will identify unmet needs, and the community level will activate resources to develop social networks to satisfy patient and family needs. A sample size of 320 patients per group per 100,000 inhabitants will offer adequate information and will give the study 80% power to detect a 20% increase in unmet needs, decrease families’ burden, improve families’ satisfaction, and decrease the use of health system resources, the primary end point. Results will be based on patients’ baseline and final analysis (after 7 weeks of the intervention). We will carry out descriptive analyses of variables related to patients’ needs and of people involved in the social network. We will analyze pre- and postintervention data for each group, including measures of central tendency, confidence intervals for the 95% average, contingency tables, and a linear regression. For continuous variables, we will use Student t test to compare independent samples with normal distribution and Mann-Whitney U test for nonnormal distributions. For discrete variables, we will use Mann-Whitney U test. For dichotomous variables we will use Pearson chi-square test. All tests will be carried out with a significance level alpha=.05. Results: Ethical approval for this study was given by the Clinical Research Committee of Andalusian Health Service, Spain (CI 1020-N-17), in June 2018. The community promoter has been identified, received an expert community-based palliative care course, and will start making contacts in the community and the palliative care teams involved in the research project. Conclusions: The results of this study will provide evidence of the benefit of the REDCUIDA protocol on the development and assessment of networks of compassionate communities at the end of life. It will provide information about clinical and emotional improvements, satisfaction, proxy burden, and health care resource consumption regarding patients in palliative care. Registered Report Identifier: RR1-10.2196/10515

  • JMIR Res Protoc 2018;7(10):e10515

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Oct 12, 2018

  Innovative Approach for Enhancing Testing of HIV, Hepatitis B, and Hepatitis C in the General Population: Protocol for an Acceptability and Feasibility Study...

  View Authors View Abstract

  Authors List:

  • Nathalie Lydié  
  • Leila Saboni  
  • Arnaud Gautier  
  • Cécile Brouard  
  • Stéphane Chevaliez  
  • Francis Barin  
  • Christine Larsen  
  • Florence Lot  
  • Delphine Rahib  

  Abstract:

  Background: Despite substantial screening for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) infections in France, a great number of infected persons remain undiagnosed. In this context, Santé publique France experimented with a new screening approach for HBV, HCV, and HIV infection, based on home self-sampling using dried blood spot (DBS) for blood collection. Objective: The objectives of the BaroTest study were to assess the acceptability and feasibility of this approach and to update the prevalence estimates of HBV, HCV, and HIV infections in the general population. Methods: Participants were enrolled using the 2016 Health Barometer, a national cross-sectional telephone survey based on a large representative sample of the general population aged 15 to 75 years (N=15,000). Upon completion of the questionnaire, any participant in the Health Barometer aged 18 to 75 years, having medical health insurance, and not under guardianship was invited to receive a self-sampling kit delivered by standard postal mail and to return the DBS card to the laboratory. The laboratory was then responsible for reporting the results to the participants. Acceptability of the protocol was based on the percentage of eligible individuals agreeing to receive the self-sampling kit, on the proportion of people returning the DBS card, and on the proportion of participants out of the total eligible population. The feasibility of the approach was based on the number of participants with adequately filled blood spots and the number of participants with blood spots for which at least one virological analysis could be performed. A complex system of reminders was implemented to increase the participation rate. Accordingly, we assumed that 35.00% (4900/14,000) of eligible persons would accept and return their DBS card. As the highest expected prevalence was for HBV infection, estimated at 0.65% in 2004, 5000 persons would make it possible to estimate this prevalence with an accuracy of approximately 0.22%. All indicators can be analyzed according to the characteristics of the participants collected in the Health Barometer questionnaire. BaroTest was approved by the French Ethics Committee (November 11, 2015) and the Commission on Information Technology and Liberties (December 24, 2015). The study has been registered by the French medical authority under number 2015-A01252-47 on November 10, 2015. Results: The results on acceptability and feasibility are expected in the last quarter of 2018 and those on the prevalence estimates in the first semester of 2019. Conclusions: The BaroTest results will help to inform new strategies for HIV, HBV, and HCV screening, and the Health Barometer provides a reliable updated assessment of the burden of HBV, HCV, and HIV infections in the general population in France while reducing the costs typically associated with this type of research. Registered Report Identifier: RR1-10.2196/9797

  • JMIR Res Protoc 2018;7(10):e180

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.