Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK
NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, School of Health Sciences, University of Manchester, Manchester, UK.
BMJ Open. 2024 Feb 24;14(2):e077958. doi: 10.1136/bmjopen-2023-077958.
Congenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9 million CYP globally. While survival rates are increasing, support for young people adjusting to life with a heart condition is lacking. Furthermore, one in three CYP with heart conditions also experiences anxiety, depression or adjustment disorder, for which little support is offered. While adults are offered cardiac rehabilitation (CR) to support their mental and physical health, this is not offered for CYP.One way to overcome this is to evaluate a CR programme comprising exercise with mental health support (CardioActive; CA) for CYP with heart conditions. The exercise and mental health components are informed by the metacognitive model, which has been shown to be effective in treating anxiety and depression in CYP and associated with improving psychological outcomes in adult CR.
The study is a single-blind parallel randomised feasibility trial comparing a CR programme (CA) plus usual care against usual care alone with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition. CA will include six group exercise, lifestyle and mental health modules. Usual care consists of routine outpatient management. Participants will be assessed at three time points: baseline, 3-month (post-treatment) and 6-month follow-up. Primary outcomes are feasibility and acceptability (ie, referral rates, recruitment and retention rates, attendance at the intervention, rate of return and level of completion of follow-up data). Coprimary symptom outcomes (Strength and Difficulties Questionnaire and Paediatric Quality of Life) and a range of secondary outcomes will be administered at each time point. A nested qualitative study will investigate CYP, parents and healthcare staff views of CR and its components, and staff's experience of delivering CA. Preliminary health economic data will be collected to inform future cost-effectiveness analyses. Descriptive data on study processes and clinical outcomes will be reported. Data analysis will follow intention to treat. Qualitative data will be analysed using thematic analysis and the theoretical framework of acceptability.
Ethical approval was granted on 14 February 2023 by the Greater Manchester East Research Ethics Committee (22/NW/0367). The results will be disseminated through peer-reviewed journals, conference presentations and local dissemination.
ISRCTN50031147; NCT05968521.
先天性心脏病是儿童和青少年（CYP）中最常见的非传染性疾病之一，全球有 1390 万 CYP 患有此病。虽然存活率在提高，但年轻患者适应心脏病生活的支持却很缺乏。此外，三分之一患有心脏病的 CYP 还会经历焦虑、抑郁或适应障碍，但很少得到支持。虽然成年人可以接受心脏康复（CR）来支持他们的身心健康，但 CYP 则没有提供这种服务。克服这个问题的一种方法是评估一个包含运动和心理健康支持的 CR 项目（CardioActive；CA），以适应 CYP 心脏病患者。运动和心理健康部分基于元认知模型，该模型已被证明在治疗 CYP 的焦虑和抑郁方面非常有效，并且与改善成人 CR 的心理结果相关。
这项研究是一项单盲平行随机可行性试验，比较了 CR 项目（CA）加常规护理与常规护理单独治疗的效果，共有 100 名 11-16 岁确诊心脏病的 CYP（每组 50 名）参与。CA 将包括六个小组运动、生活方式和心理健康模块。常规护理包括常规门诊管理。参与者将在三个时间点进行评估：基线、3 个月（治疗后）和 6 个月随访。主要结果是可行性和可接受性（即转诊率、招募和保留率、干预的出勤率、随访数据的返回率和完成率）。主要症状结果（困难问卷和儿科生活质量）和一系列次要结果将在每个时间点进行评估。一项嵌套的定性研究将调查 CYP、家长和医护人员对 CR 及其组成部分的看法，以及工作人员提供 CA 的经验。初步健康经济数据将收集，以告知未来的成本效益分析。研究过程和临床结果的描述性数据将报告。数据分析将遵循意向治疗原则。定性数据将使用主题分析和可接受性的理论框架进行分析。
Greater Manchester East 研究伦理委员会于 2023 年 2 月 14 日批准了该研究（22/NW/0367）。结果将通过同行评议期刊、会议报告和当地传播进行传播。
ISRCTN50031147；NCT05968521。
