Cardiac Rehabilitation for Children and Young People (CardioActive): Protocol for a Single-Blind Randomized Feasibility and Acceptability Study of a centre based cardiac rehabilitation programme versus usual care in 11-16-year-olds with heart conditions.

Lora Capobianco, Mark Hann, Emma Mcmanus, Sarah Peters, Patrick Doherty, Giovanna Ciotti, Joanne Murray, Adrian Wells

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Congenital heart conditions are amongst 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, 1 in 3 CYP with heart conditions also experience 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 shown to be effective in treating anxiety and depression in CYP and associated with improving psychological outcomes in adult CR.

Method and Analysis: The study is a single blind parallel randomized 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 (i.e., referral rates, recruitment and retention rates, attendance at the intervention, rate of return and level of completion of follow up data). Co-primary 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.
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 14 Dec 2023

Keywords

  • cadiac
  • youth
  • Mental health
  • metacognition
  • metacognitive therapy
  • rehabilitation

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