Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PR, UK.
Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK.
Trials. 2018 Oct 4;19(1):537. doi: 10.1186/s13063-018-2923-x.
Coronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehabilitation optimises patient outcomes. However, a high percentage of these services do not meet necessary performance indicators such as course length and follow-up attendance. Uptake of such services is only 50% in UK patients and support provided 12 months after an event is often limited. To delay and prevent further CHD events leading to hospitalisation, supplementary self-management strategies such as group education, are necessary.
This is a single-centre, randomised controlled trial (RCT) recruiting participants (n = 290) aged ≥18 years who are 12 to 48 months post diagnosis of a CHD-related cardiac event (myocardial infarction, angina and any other acute coronary syndrome). The study aims to implement a structured education programme, with text-message support over 12 months, and identify whether delivery of the programme, to individuals who have a history of a cardiac event, would be an effective and cost-effective strategy for increasing walking. The primary outcome, objectively measured average daily physical activity, specifically step count through walking activity, is assessed using the wrist-worn GENEActiv accelerometer at baseline, 6 and 12 months. Secondary outcomes at 12 months include cardiovascular risk factors such as smoking status, blood pressure, lipid profile, glycated haemoglobin (HbA1c), obesity, self-efficacy, quality of life, physical activity and physical function. Participants are randomised to either the control group receiving standard care and a physical activity information leaflet, or the intervention group whose partcipants receive the leaflet and are invited to attend two group-based structured education sessions. These encourage participants to adopt and maintain healthy behaviours and self-manage their lifestyle. They are delivered approximately 2 weeks apart by trained facilitators and reinforced via subsequent text-message support.
To our knowledge, this is the first trial designed to assess the effectiveness of a group education programme 12 to 48 months after a CHD event diagnosis. If successful, the PACES programme could be translated into effective post-operative cardiac care and complement the current post-operative services available.
ISRCTN, ID: ISRCTN91163727 . The trial was registered on 27 February 2017.
冠心病（CHD）约占全球死亡人数的 13%，是英国的主要死亡原因，且与之相关的医疗保健费用相当高。CHD 事件发生后，及时进行心脏康复可以优化患者的治疗效果。然而，这些服务中有很大一部分都不符合必要的绩效指标，例如疗程长度和随访出席率。在英国患者中，此类服务的采用率仅为 50%，而在事件发生后 12 个月提供的支持往往也很有限。为了延迟和预防导致住院的进一步 CHD 事件，需要采用如团体教育等补充性自我管理策略。
这是一项单中心、随机对照试验（RCT），招募年龄≥18 岁的参与者（n=290），他们在诊断出与 CHD 相关的心脏事件（心肌梗死、心绞痛和任何其他急性冠状动脉综合征）后 12 至 48 个月。该研究旨在实施一项结构化的教育计划，并通过短信支持在 12 个月内提供该计划，以确定针对有心脏事件史的个体提供该计划是否是一种有效且具有成本效益的策略，从而提高他们的步行量。主要结局是通过佩戴在手腕上的 GENEActiv 加速度计在基线、6 个月和 12 个月时客观测量的平均每日体力活动，具体表现为步行活动的步数。次要结局包括心血管风险因素，如吸烟状况、血压、血脂谱、糖化血红蛋白（HbA1c）、肥胖、自我效能、生活质量、体力活动和身体机能，这些结局都将在 12 个月时评估。参与者被随机分配到对照组（接受标准护理和一份关于体力活动的宣传册）或干预组（参与者除了接受宣传册，还被邀请参加两次基于小组的结构化教育课程）。这些课程鼓励参与者采用并保持健康的行为，并自我管理他们的生活方式。课程由经过培训的讲师大约每两周进行一次授课，并通过后续的短信支持进行强化。
据我们所知，这是第一项旨在评估 CHD 事件诊断后 12 至 48 个月时团体教育计划有效性的试验。如果成功，PACES 计划可以转化为有效的术后心脏护理，并补充当前可用的术后服务。
ISRCTN，ID：ISRCTN91163727。试验于 2017 年 2 月 27 日注册。
