Lokker Cynthia, Jezrawi Rita, Gabizon Itzhak, Varughese Jobin, Brown Michael, Trottier Dan, Alvarez Elizabeth, Schwalm Jon-David, McGillion Michael, Ma Jinhui, Bhagirath Vinai
Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Department of Cardiology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
JMIR Res Protoc. 2021 Feb 1;10(2):e26155. doi: 10.2196/26155.
Mobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies.
The overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension.
For this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants.
The development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group.
This study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health.
ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/26155.
移动健康（mHealth）干预措施可通过改善心血管危险因素来促进健康，但医生和患者在医疗中对其的采用情况尚未得到充分开发。很少有移动健康应用程序在临床试验中得到评估，并且由于技术发展迅速，之前评估的那些应用程序在试验结果可用时往往已经过时。鉴于该领域变化迅速，用当前方法对移动健康应用程序进行严格评估是不可行的。
本试点研究的总体目标是通过评估一款针对高血压的应用程序，测试使用名为“试用我的应用程序”（Trial My App）的网络研究平台对与心血管危险因素患者相关的移动健康应用程序进行高效且严格的基于网络的随机对照试验（RCT）的可行性。
对于本研究，将通过时事通讯、媒体和互联网上的广告，以及医疗服务提供者的推荐，招募200名高血压控制不佳的参与者。筛查、同意、随机分组以及收集对患者重要的健康信心和自我管理能力结果将通过“试用我的应用程序”研究平台在线进行。参与者将被随机分为两组：100名使用移动健康应用程序来跟踪高血压，100名作为教育对照组。所有参与者将在入组后的0、1、3和6个月完成问卷调查。将对40名参与者进行一项子研究，以验证血压读数方法以及通过“试用我的应用程序”输入数据的一致性。
“试用我的应用程序”网络平台的开发已完成。已与我们的患者合作伙伴和咨询委员会合作完成了调查工具的创建。预计招募工作将于2021年第一季度开始；数据收集和分析预计在研究开始后约1年完成。结果将通过会议和出版物进行传播。本研究的主要结果包括通过报告招募、留存和完成统计数据来证明使用“试用我的应用程序”平台进行随机对照试验的可行性。我们将使用标准的7天家庭血压测量方法来验证应用程序输入的数据。最后，这项试点、非盲法随机对照试验将评估与教育对照组中的高血压控制相比，移动健康应用程序在改善高血压控制方面的有效性。
本研究将确定使用基于网络的“试用我的应用程序”平台评估针对心血管危险因素患者的移动健康应用程序的有效性是否可行。随着更多移动健康应用程序在随机对照试验中得到评估，患者将能够选择满足其需求的应用程序，医生也将能够为其患者就旨在改善心血管健康的应用程序提出基于证据的建议。
ClinicalTrials.gov NCT04528654；https://clinicaltrials.gov/ct2/show/NCT04528654。
国际注册报告识别码（IRRID）：PRR1-10.2196/26155。
