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使用个性化的以患者为中心的网络应用程序对冠心病患者进行心脏远程康复的效果:SmartCare-CAD随机对照试验方案

Effects of cardiac telerehabilitation in patients with coronary artery disease using a personalised patient-centred web application: protocol for the SmartCare-CAD randomised controlled trial.

作者信息

Brouwers Rutger W M, Kraal Jos J, Traa Simone C J, Spee Ruud F, Oostveen Laurence M L C, Kemps Hareld M C

机构信息

Department of Cardiology, Máxima Medical Centre, Eindhoven/Veldhoven, The Netherlands.

FLOW Centre for Rehabilitation and Prevention in chronic disease, Máxima Medical Centre, Eindhoven/Veldhoven, The Netherlands.

出版信息

BMC Cardiovasc Disord. 2017 Jan 31;17(1):46. doi: 10.1186/s12872-017-0477-6.

Abstract

BACKGROUND

Cardiac rehabilitation has beneficial effects on morbidity and mortality in patients with coronary artery disease, but is vastly underutilised and short-term improvements are often not sustained. Telerehabilitation has the potential to overcome these barriers, but its superiority has not been convincingly demonstrated yet. This may be due to insufficient focus on behavioural change and development of patients' self-management skills. Moreover, potentially beneficial communication methods, such as internet and video consultation, are rarely used. We hypothesise that, when compared to centre-based cardiac rehabilitation, cardiac telerehabilitation using evidence-based behavioural change strategies, modern communication methods and on-demand coaching will result in improved self-management skills and sustainable behavioural change, which translates to higher physical activity levels in a cost-effective way.

METHODS

This randomised controlled trial compares cardiac telerehabilitation with centre-based cardiac rehabilitation in patients with coronary artery disease. We randomise 300 patients entering cardiac rehabilitation to centre-based cardiac rehabilitation (control group) or cardiac telerehabilitation (intervention group). The core component of the intervention is a patient-centred web application, which enables patients to adjust rehabilitation goals, inspect training and physical activity data, share data with other caregivers and to use video consultation. After six supervised training sessions, the intervention group continues exercise training at home, wearing an accelerometer and heart rate monitor. In addition, physical activity levels are assessed by the accelerometer for four days per week. Patients upload training and physical activity data weekly and receive feedback through video consultation once a week. After completion of the rehabilitation programme, on-demand coaching is performed when training adherence or physical activity levels decline with 50% or more. The primary outcome measure is physical activity level, assessed at baseline, three months and twelve months, and is calculated from accelerometer and heart rate data. Secondary outcome measures include physical fitness, quality of life, anxiety and depression, patient empowerment, patient satisfaction and cost-effectiveness.

DISCUSSION

This study is one of the first studies evaluating effects and costs of a cardiac telerehabilitation intervention comprising a combination of modern technology and evidence-based behavioural change strategies including relapse prevention. We hypothesise that this intervention has superior effects on exercise behaviour without exceeding the costs of a traditional centre-based intervention.

TRIAL REGISTRATION

Netherlands Trial Register NTR5156 . Registered 22 April 2015.

摘要

背景

心脏康复对冠心病患者的发病率和死亡率具有有益影响,但目前该疗法的利用率极低,且短期改善效果往往难以持续。远程康复有可能克服这些障碍,但其优越性尚未得到令人信服的证明。这可能是由于对行为改变和患者自我管理技能培养的关注不足。此外,诸如互联网和视频咨询等潜在有益的沟通方式很少被使用。我们假设,与基于中心的心脏康复相比,采用循证行为改变策略、现代沟通方式和按需指导的心脏远程康复将提高自我管理技能并促成可持续的行为改变,从而以具有成本效益的方式提高身体活动水平。

方法

本随机对照试验将冠心病患者的心脏远程康复与基于中心的心脏康复进行比较。我们将300名接受心脏康复的患者随机分为基于中心的心脏康复组(对照组)或心脏远程康复组(干预组)。干预的核心组成部分是一个以患者为中心的网络应用程序,该程序使患者能够调整康复目标、查看训练和身体活动数据、与其他护理人员共享数据以及使用视频咨询。在进行六次有监督的训练课程后,干预组在家中继续进行运动训练,佩戴加速度计和心率监测器。此外,每周有四天通过加速度计评估身体活动水平。患者每周上传训练和身体活动数据,并每周通过视频咨询获得一次反馈。在康复计划完成后,当训练依从性或身体活动水平下降50%或更多时,进行按需指导。主要结局指标是身体活动水平,在基线、三个月和十二个月时进行评估,并根据加速度计和心率数据计算得出。次要结局指标包括身体素质、生活质量、焦虑和抑郁情况、患者赋权、患者满意度以及成本效益。

讨论

本研究是首批评估包含现代技术与循证行为改变策略(包括预防复发)相结合的心脏远程康复干预效果和成本的研究之一。我们假设这种干预对运动行为具有卓越效果,且不会超出传统基于中心干预的成本。

试验注册

荷兰试验注册库NTR5156。于2015年4月22日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bc0/5282829/0d5c44c39940/12872_2017_477_Fig1_HTML.jpg

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