Department of Cardiovascular Medicine Mayo Clinic College of Medicine Rochester MN.
Center for Health Equity and Community Engagement Research Mayo Clinic Rochester MN.
J Am Heart Assoc. 2023 Dec 5;12(23):e030883. doi: 10.1161/JAHA.123.030883. Epub 2023 Nov 28.
Innovative restructuring of cardiac rehabilitation (CR) delivery remains critical to reduce barriers and improve access to diverse populations. is a novel virtual world technology-based CR program delivered through the virtual world platform, Second Life, which previously demonstrated high acceptability as an extension of traditional center-based CR. This study aims to evaluate efficacy and adherence of the virtual world-based CR program compared with center-based CR within a community-informed, implementation science framework.
Using a noninferiority, hybrid type 1 effectiveness-implementation, randomized controlled trial, 150 patients with an eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. Participants will be randomized 1:1 to either the 12-week or the center-based CR control groups. The primary efficacy outcome is a composite cardiovascular health score based on the American Heart Association Life's Essential 8 at 3 and 6 months. Adherence outcomes include CR session attendance and participation in exercise sessions. A diverse patient/caregiver/stakeholder advisory board was assembled to guide recruitment, implementation, and dissemination plans and to contextualize study findings. The institutional review board-approved randomized controlled trial will enroll and randomize patients to the intervention (or control group) in 3 consecutive waves/year over 3 years. The results will be published at data collection and analyses completion.
The randomized controlled trial tests an innovative and potentially scalable model to enhance CR participation and advance health equity. Our findings will inform the use of effective virtual CR programs to expand equitable access to diverse patient populations.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05897710.
创新的心脏康复（CR）服务结构调整对于减少障碍和改善不同人群的获得途径仍然至关重要。 是一种新颖的基于虚拟世界技术的 CR 项目，通过虚拟世界平台 Second Life 提供，该项目之前作为传统中心式 CR 的扩展，已被证明具有很高的可接受性。本研究旨在评估基于虚拟世界的 CR 项目与中心式 CR 在社区知情、实施科学框架内的疗效和依从性。
本研究采用非劣效性、混合 1 型有效性-实施随机对照试验，将从美国 6 个地理位置不同的 CR 中心招募 150 名符合条件的心血管事件患者。参与者将以 1:1 的比例随机分配到 12 周的 或中心式 CR 对照组。主要疗效结局是基于美国心脏协会生命必需 8 项的心血管健康综合评分，在 3 个月和 6 个月时进行评估。依从性结局包括 CR 课程出勤率和参加运动课程的情况。一个由多样化的患者/护理人员/利益相关者顾问委员会组成，以指导招募、实施和传播计划，并使研究结果具有背景意义。机构审查委员会批准的随机对照试验将在 3 年内分 3 个连续波/年招募和随机分配患者进入干预（或对照组）。结果将在数据收集和分析完成后公布。
这项 随机对照试验测试了一种创新且潜在可扩展的模型，以增强 CR 的参与度并促进健康公平。我们的研究结果将为使用有效的虚拟 CR 项目提供信息，以扩大对不同患者群体的公平获得途径。
