Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Retention Rate (Feasibility Outcome)
研究概览
简要总结
Heart problems are amongst the most common physical illnesses in children and young people (CYP). They can be present from birth or develop as CYP get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life.
While adults are offered exercise classes and lifestyle advice after a heart problem, CYP with heart problems are not. Improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes).
Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also important to support their mental health. One way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of exercise with mental health support for CYP.
The aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of allocation will be maintained for the principal investigator's, statistician, and quantitative research assistant.
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •Consent to participate
- •Diagnosed with at least one of the following:
- •Congenital heart disease (all subtypes)
- •Cardiomyopathy
- •Cardiac arrhythmia
- •Heart failure
- •Post-cerebrovascular event
- •Post-heart valve repair/replacement
排除标准
- •Significant risk or safeguarding concerns (i.e., suicidal ideation)
- •Head injury/organic impairment
- •Significant social and/or communication difficulties
- •Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
研究组 & 干预措施
Cardiac Rehabilitation (Intervention)
Participants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component.
干预措施: Cardiac Rehabilitation (CR): Experimental (Behavioral)
Treatment as usual (Control)
Participants allocated to the control group will receive treatment as usual.
干预措施: Treatment as usual: Control (Behavioral)
结局指标
主要结局
Retention Rate (Feasibility Outcome)
时间窗: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)
Intervention Attendance (Feasibility Outcome)
时间窗: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).
Recruitment Rate (Feasibility Outcome)
时间窗: Date of Baseline Assessment to end of follow-up (24 week follow up)
Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).
Acceptability of the Intervention
时间窗: Date of Baseline Assessment to end of follow-up (24 week follow up)
Acceptability of the intervention will be assessed in qualitative semi-structured interviews with children and young people, caregivers, and healthcare professionals, which will assess individuals views on the intervention, targets for improvement, and perceived acceptability of the components of the cardiac rehabilitation programme.
次要结局
- Strength and Difficulties Questionnaire (SDQ)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Child Health Utility-9D (CHU-9D)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Incremental Shuttle Walk Test (ISWT)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Physical Activity Monitoring(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Metacognition Questionnaire-Adolescent (MCQ-A)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Health and Social Care Service-Use Questionnaire(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Demographics Questionnaire(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Six minute walk test (6MWT)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
- Paediatric Quality of Life (PedsQol)(Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up))
研究者
Lora Capobianco
Principal Investigator
Greater Manchester Mental Health NHS Foundation Trust