RecoveryPlus.Health, Inc, New York, NY, United States.
Node.Health Foundation, Wilmington, DE, United States.
JMIR Mhealth Uhealth. 2024 Oct 1;12:e59098. doi: 10.2196/59098.
Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD.
We aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD.
This 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables.
In total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants' performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey's physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported.
The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States.
ClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500.
心脏康复(CR)是一种针对心血管疾病(CVD)患者的安全、有效的干预措施。然而,大多数符合条件的患者都无法完成 CR。越来越多的证据表明,基于家庭的心脏康复(HBCR)计划在有效性和安全性方面与传统的基于中心的计划相当。需要更多的研究来探索为 CVD 患者提供 HBCR 计划的不同方法。
我们旨在评估一种数字 HBCR 计划(RecoveryPlus.Health)的可行性和影响,该计划整合了远程医疗和移动医疗模式,以提高成年人 CVD 患者的功能性运动能力、静息心率和生活质量。
这是一项前瞻性、单臂远程临床试验,采用自身对照设计。我们于 2023 年 5 月至 8 月期间从社区招募了有 CR 资格的 CVD 成年人(年龄≥40 岁),其诊断包括稳定型心绞痛、心肌梗死和心力衰竭。所有入组患者均转诊至德克萨斯州罗阿诺克的 RPH 诊所。护理团队通过两种模式为研究参与者提供符合指南的 CR 服务:(1)通过视频会议进行同步远程健康锻炼培训;(2)使用异步移动健康(mHealth)教练应用程序(RPH 应用程序)。基线摄入调查、电子健康记录和应用程序日志数据用于提取个体特征、护理流程和平台参与数据。通过方案完成率和 CR 服务使用率来衡量可行性。通过 12 周方案前后的 6 分钟步行测试、静息心率和生活质量(12 项简短健康调查)的变化来衡量疗效。采用配对 t 检验来检验结局变量的干预前后变化。
共有 162 人符合纳入标准,其中 75 人(46.3%)同意并入组(平均年龄 64 岁,标准差 10.30 岁;男性:n=37,49%;白人:n=46,61%)。心力衰竭是最常见的诊断(37/75,49%)。共有 62/75(83%)名参与者完成了 12 周的研究,并使用了远程医疗模式,完成了 9.63(SD 3.33)次会话,59/75(79%)使用了移动健康模式,完成了 10.97(SD 11.70)次会话。干预后,62/62(81%)名参与者的 6 分钟步行测试表现有所改善,平均提高了 40(SD 63.39)米(95%置信区间 25.6-57.1)。12 项简短健康调查的身体和心理综合评分分别提高了 2.7(SD 6.47)分(95%置信区间 1.1-4.3)和 2.2(SD 9.09)分(95%置信区间 0.1-4.5)。静息心率没有变化,也没有报告与运动相关的不良事件。
RecoveryPlus.Health 数字 HBCR 方案在一组全国招募的 CVD 患者中显示出了可行性和疗效。这些发现增加了证据,表明远程医疗和移动医疗双重模式的 HBCR 方案可能是改善美国 CR 可及性的一种有前途的方法。
ClinicalTrials.gov NCT05804500;https://clinicaltrials.gov/search?cond=NCT05804500。