ISRCTN50031147Active, not recruitingUnknown
Cardiac rehabilitation for young people: a single-blind randomised acceptability and feasibility study of an integrated physical and mental health approach
Greater Manchester Mental Health NHS Foundation Trust0 sites100 target enrollmentStarted: April 13, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Enrollment
- 100
Study Overview
Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38401897/ (added 26/02/2024)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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.
Investigators
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