Cardiac rehabilitation for children and young people

Not Applicable

Conditions: Cardiovascular and mental health in children and young people
Not Applicable

Registration Number: ISRCTN50031147

Lead Sponsor: Greater Manchester Mental Health NHS Foundation Trust

Brief Summary: 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38401897/ (added 26/02/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Aged between 11-16 years
2. Fluent in English
3. Consent given to participate
4. Diagnosed with at least one of the following:
4.1. Congenital heart disease (all subtypes)
4.2. Cardiomyopathy
4.3. Cardiac arrhythmia
4.4. Heart failure
4.5. Post-cerebrovascular event
4.6. Post-heart valve repair/replacement

Exclusion Criteria

Current exclusion criteria as of 06/07/2023:
1. Significant risk or safeguarding concerns (i.e. suicidal ideation)
2. Head injury/organic impairment
3. Significant communication and/or social difficulties

Note: Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.
_____

Previous exclusion criteria as of 26/05/2023:
1. Significant risk or safeguarding concerns (i.e., suicidal ideation)
2. Head injury/organic impairment
3. Learning disability causing communication difficulties

Note: Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.

____

Previous exclusion criteria:
1. Significant risk or safeguarding concerns (i.e., suicidal ideation)
2. Head injury/organic impairment
3. Autism Spectrum Disorder

Note: Those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 06/07/2023:<br>The following primary outcome measures will be assessed from baseline to end of follow-up:<br>1. Feasibility will be assessed using referral rates (baseline), recruitment and retention rates (baseline, 12 weeks, 24 weeks), participant attendance at CR, and willingness to be randomized to treatment<br>2. Acceptability of the intervention will be assessed in qualitative focus groups and semi- structured interviews with children and young people, caregivers, and healthcare professionals<br>_____<br><br>Previous primary outcome measures:<br>The following primary outcome measures were assessed at baseline, and 12 and 24 weeks<br>1. Psychological wellbeing measured using the Strength and Difficulties Questionnaire (SDQ) <br>2. Quality of life measured using the Paediatric Quality of Life (PedsQol)

Secondary Outcome Measures