CardioActive
Dr Lora Capobianco
Chief Investigator
3-year project
study name
Cardiac Rehabilitation for Young People (CardioActive)
CardioActive is an NIHR funded research study (NIHR203634) looking at group cardiac rehabilitation (CR) for children and young people (CYP) with heart conditions.
Study Participants
- Children or young people (aged 11-16)
- Diagnosed with a heart condition.
Study Design
- CardioActive is a single-blind randomised feasibility study with two conditions: the CardioActive programme vs. treatment as usual (TAU).
- We plan to recruit 100 participants (50 in each arm).
- They will be randomised (like flipping a coin) to one of two groups: CardioActive or TAU.
- All participants will complete questionnaires at baseline, 12 weeks (post-treatment), and 24 weeks (follow-up).
- A qualitative study will explore patient, caregiver, and staff attitudes and views towards the CardioActive programme.
CardioActive
- 13.8 million CYP under the age of 20 have a childhood heart condition globally.
- CYP face challenges which impact their ability to function, future employment, overprotection, and progression into independent adulthood.
- 41% of CYP with heart conditions experience significant difficulties adjusting to their heart condition and approximately 30% experience clinically significant anxiety or depression.
- We aim to see if participating in a randomised trial of a CR programme (CardioActive) plus usual care is a feasible and acceptable treatment for CYP with heart conditions in comparison to usual care alone.
- We will first aim to answer the questions can this study design work and what do patients, caregivers, and health professions think of the programme.
- Results of this study will allow the research team to answer key questions about whether running a larger-scale, definite trial is an acceptable, feasible, and effective option.
- We are looking for young people with experience of a heart condition and caregivers to advise the research team on this project by providing feedback on plans, approach, and language. For more information, please CLICK HERE
- We aim to see if participating in a randomised trial of a CR programme (CardioActive) plus usual care is a feasible and acceptable treatment for with CYP with heart conditions in comparison to usual care alone.
- We will first aim to answer the questions can this study design work and what do patients, caregivers, and health professions think of the programme.
- Results of this study will allow the research team to answer key questions about whether running a larger-scale, definite trial is an acceptable, feasible, and effective option.
- The trial will take place at Manchester Children’s Hospital.
- Recruitment for the trial is expected to begin in March 2024
Participants Recruited
- Patients and public play a key role in ensuring research is accessible, meets patient’s needs, and provides direct benefit to patients.
- We are currently looking for both adult and youth members of the public who would be interested in being involved in patient and public involvement (PPI) groups for the CardioActive study.
- We are looking for a range of service users to join our PPI groups which include: 1) CYP with heart conditions, (2) Adults with lived experience of a heart condition, (3) Parents/caregivers of CYP with heart conditions.
- If you are interested in being part of our PPI group or would like further information, please contact Noor Nasseri: noor.nasseri@gmmh.nhs.uk
- To hear what our service users have to say about being a PPI member please CLICK HERE
- The CYP taking part in CardioActive and who receive CR will be invited for an interview to explore their experience and their thoughts about the programme (for example, things they liked or disliked).
- The interviews are an optional, additional part to the CardioActive trial and participation will be voluntary.
- The interviews will last between 30 and 60 minutes and will be audio-recorded with a written record (also known as a transcript) made so that we can accurately represent what was said in the interview. The records will be anonymous and confidential, any identifying information such as names, dates, or places will be removed.
- The interviews will help us to understand if CR is useful for improving the mental and physical health of young people with heart conditions. These interviews will also help shape the CardioActive programme for the future and help us to identify any areas of the programme that may need changing.
- The interviews will take place either in-person or online, and participants will be compensated for their time. If you have been contacted about taking part in an interview and have any questions, please get in touch HERE.
- Background
-
- 13.8 million CYP under the age of 20 have a childhood heart condition globally.
- CYP face challenges which impact their ability to function, future employment, overprotection, and progression into independent adulthood.
- 41% of CYP with heart conditions experience significant difficulties adjusting to their heart condition and approximately 30% experience clinically significant anxiety or depression.
- What does the study aim to achieve?
-
- We aim to see if participating in a randomised trial of a CR programme (CardioActive) plus usual care is a feasible and acceptable treatment for CYP with heart conditions in comparison to usual care alone.
- We will first aim to answer the questions can this study design work and what do patients, caregivers, and health professions think of the programme.
- Results of this study will allow the research team to answer key questions about whether running a larger-scale, definite trial is an acceptable, feasible, and effective option.
- We are looking for young people with experience of a heart condition and caregivers to advise the research team on this project by providing feedback on plans, approach, and language. For more information, please CLICK HERE
- Treatment
-
- We aim to see if participating in a randomised trial of a CR programme (CardioActive) plus usual care is a feasible and acceptable treatment for with CYP with heart conditions in comparison to usual care alone.
- We will first aim to answer the questions can this study design work and what do patients, caregivers, and health professions think of the programme.
- Results of this study will allow the research team to answer key questions about whether running a larger-scale, definite trial is an acceptable, feasible, and effective option.
- Current Study Progress
-
- The trial will take place at Manchester Children’s Hospital.
- Recruitment for the trial is expected to begin in March 2024
Participants Recruited
- Patient and Public Involvement (PPI)
-
- Patients and public play a key role in ensuring research is accessible, meets patient’s needs, and provides direct benefit to patients.
- We are currently looking for both adult and youth members of the public who would be interested in being involved in patient and public involvement (PPI) groups for the CardioActive study.
- We are looking for a range of service users to join our PPI groups which include: 1) CYP with heart conditions, (2) Adults with lived experience of a heart condition, (3) Parents/caregivers of CYP with heart conditions.
- If you are interested in being part of our PPI group or would like further information, please contact Noor Nasseri: noor.nasseri@gmmh.nhs.uk
- To hear what our service users have to say about being a PPI member please CLICK HERE
- Interviews
-
- The CYP taking part in CardioActive and who receive CR will be invited for an interview to explore their experience and their thoughts about the programme (for example, things they liked or disliked).
- The interviews are an optional, additional part to the CardioActive trial and participation will be voluntary.
- The interviews will last between 30 and 60 minutes and will be audio-recorded with a written record (also known as a transcript) made so that we can accurately represent what was said in the interview. The records will be anonymous and confidential, any identifying information such as names, dates, or places will be removed.
- The interviews will help us to understand if CR is useful for improving the mental and physical health of young people with heart conditions. These interviews will also help shape the CardioActive programme for the future and help us to identify any areas of the programme that may need changing.
- The interviews will take place either in-person or online, and participants will be compensated for their time. If you have been contacted about taking part in an interview and have any questions, please get in touch HERE.
CardioActive Project Timeline
Stage 1
Stage 1
—
(Months 1-19) commenced in September 2022. Project set up, ethical approval, development of the CardioActive programme manual, PPI groups, qualitative interviews, and staff training.
Stage 2
Stage 2
—
(Months 19-28) due to commence in March 2024. Participant recruitment, programme delivery, and collection of end of treatment and follow-up data collection.
Stage 3
Stage 3
—
(Months 28-36) due to commence in December 2024. Data cleaning and analysis, project write-up, and dissemination.
CardioActive FAQs
