Sakakibara Brodie M, Chakrabarti Santabhanu, Krahn Andrew, Mackay Martha H, Sedlak Tara, Singer Joel, Whitehurst David Gt, Lear Scott A
Faculty of Health Sciences, Simon Fraser University, Vancouver, BC, Canada.
Division of Cardiology, Providence Health Care, Vancouver, BC, Canada.
JMIR Res Protoc. 2019 Jan 11;8(1):e12322. doi: 10.2196/12322.
Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed.
In this paper, we report on a protocol to evaluate Healing Circles-an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care.
In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months.
The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019.
Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use.
ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12322.
心血管疾病（CVD）是全球住院和死亡的主要原因。心血管疾病的患病率正在上升，因此，需要开发和研究有效的项目，以帮助人们更好地自我管理心血管疾病并预防继发性并发症。
在本文中，我们报告了一项评估康复圈（Healing Circles）的方案，这是一个基于证据且以患者为导向的同伴支持移动健康项目，旨在促进自我管理并支持心血管疾病患者康复和管理疾病。我们假设，使用康复圈的心血管疾病患者在自我管理能力方面的改善将比接受常规护理的患者更大。
在这项单盲（评估者）随机对照试验中，250名患有心血管疾病的社区居民将按1:1的比例随机分为康复圈组或常规护理组。自我管理的主要结局将使用3.0版《健康教育影响问卷》进行测量。次要结局包括慢性病管理的自我效能感、健康相关生活质量、健康资源使用和成本以及电子健康素养。将在基线时以及之后的24个月内每6个月进行一次测量。
该研究于2017年9月开始招募。目前正在招募参与者，现有参与者正在接受随访。将每6个月进行一次测量，直至研究结束，预计在2019年12月结束。
康复圈是一个旨在通过同伴支持改善自我管理的新型项目。鉴于我们的实际研究设计，我们的研究结果将很容易转化为实践。如果结果支持我们的假设，这将表明康复圈是改善自我管理和减少医疗保健使用的有效干预措施。
ClinicalTrials.gov NCT03159325；https://clinicaltrials.gov/ct2/show/NCT03159325（由WebCite存档于http://www.webcitation.org/74DvxVKUd）。
国际注册报告识别码（IRRID）：DERR1-10.2196/12322。
