Heart2Heart: a digital peer support programme for people with heart disease: protocol for a community-based, investigator-blinded randomised controlled trial conducted in Australia.

IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL BMJ Open Pub Date : 2025-02-13 DOI:10.1136/bmjopen-2024-088740
Julie Redfern, Emily Li, Andrew Maiorana, Robert Zecchin, Karice K Hyun, Wendan Shi, Joseph Weddell, Shuang Liang, Dion Candelaria, Tom Briffa, Adrian Bauman, Gemma Figtree, Maree L Hackett, Chi Kin Law, Qiang Tu, Richard Lindley, Robyn Gallagher
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Abstract

Introduction: Cardiac rehabilitation is known to reduce morbidity and improve quality of life in people living with heart disease, however, adherence, access and completion of these programmes is suboptimal. Peer support may offer an opportunity to close this service gap. The aim of the study is to determine whether the effectiveness of a digital peer support programme for people living with heart disease is effective in improving social connectedness, clinical and patient-reported outcomes and experience measures.

Methods and analysis: Heart2Heart is a community-based randomised controlled trial with 6 months follow-up for the primary outcome and 6 and 12 months for secondary outcomes. Approximately 752 adults with a diagnosis of heart disease in the past 12 months will be recruited from the general community and Australian cardiac rehabilitation programmes. Control group will participate in usual care, while intervention group will have access to a 6 months intervention that enables peer support via an interactive mobile application, in addition to usual care. The intervention includes online discussion groups, access to resources and facilitated conversations with health professionals. Primary outcome is social connectedness at 6 months follow-up. Secondary outcomes (6 and 12 months) will be all-cause/cardiovascular disease hospital admissions, all-cause mortality, lifestyle (sufficiently physically active, not smoking, sufficient fruit and vegetable consumption), proportion taking prescribed medications and health service utilisation (medical appointments, cardiac rehabilitation, participation in any other in-person peer support activities). Patient-reported outcome and experience measures including self-efficacy, quality of life, satisfaction and programme engagement will be analysed at 6 months. Process measures will include application analytics, barriers and facilitators to engagement with the intervention from participant's perspective. An intention-to-treat analysis will be used.

Ethics and dissemination: Ethical clearance was obtained from Western Sydney Local Health District Ethics Committee. Heart2Heart has potential to improve social connectedness and provide a valuable addition to traditional cardiac rehabilitation.

Trial registration number: ACTRN12624000386538.

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Heart2Heart:心脏病患者的数字同伴支持计划:在澳大利亚进行的基于社区、研究者盲法随机对照试验的协议。
导读:众所周知,心脏康复可以降低心脏病患者的发病率并改善其生活质量,然而,这些方案的依从性、可及性和完成度并不理想。同伴支持可能会提供一个机会来缩小这种服务差距。该研究的目的是确定数字同伴支持计划对心脏病患者的有效性是否有效,以改善社会联系,临床和患者报告的结果以及经验措施。方法和分析:Heart2Heart是一项基于社区的随机对照试验,主要结局随访6个月,次要结局随访6个月和12个月。在过去的12个月里,将从普通社区和澳大利亚心脏康复项目中招募大约752名被诊断为心脏病的成年人。对照组将参加常规护理,而干预组将获得为期6个月的干预,除了常规护理外,还可以通过交互式移动应用程序获得同伴支持。干预措施包括在线讨论组、获取资源和促进与卫生专业人员的对话。在6个月的随访中,主要结果是社会联系。次要结果(6个月和12个月)将是全因/心血管疾病住院、全因死亡率、生活方式(足够的体力活动、不吸烟、足够的水果和蔬菜消费)、服用处方药的比例和卫生服务的利用(医疗预约、心脏康复、参与任何其他面对面的同伴支持活动)。患者报告的结果和经验措施包括自我效能、生活质量、满意度和项目参与将在6个月时进行分析。过程度量将包括应用程序分析、障碍和促进因素,以便从参与者的角度参与干预。将使用意向治疗分析。伦理和传播:获得了西悉尼地方卫生区伦理委员会的伦理许可。Heart2Heart有可能改善社会联系,并为传统的心脏康复提供有价值的补充。试验注册号:ACTRN12624000386538。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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