CardioActive study reaches its 100th participant!
Research & Innovation at Greater Manchester Mental Health NHS Foundation Trust (GMMH) celebrates a significant milestone for the CardioActive study, which evaluates group cardiac rehabilitation for children and young people with heart conditions. We talk to GMMH colleague Dr. Lora Capobianco about the study, and how GMMH is supporting mental health and collaborating with other NHS Trusts in Greater Manchester.
Congenital heart conditions affect 13.9 million children and young people globally,1 with 41% experiencing difficulties adjusting to their heart condition, and approximately one in three experiencing clinically significant anxiety or depression.2 However, cardiac rehabilitation to support mental and physical health is only offered to adults.
“This is what we wanted to address – children and young people with heart conditions face a significant number of challenges, yet a structured programme to support them to live with their heart condition that draws on mental and physical health support based on psychological theory has yet to be offered,” says Dr Lora Capobianco, Senior Research Fellow at GMMH and Chief Investigator of the CardioActive study.
Image: Dr Lora Capobianco
Starting in September 2022, the study team developed the CardioActive programme, working with a number of service users who have experienced heart conditions and their loved ones to make sure that the programme would be accessible, meet their needs and provide a direct benefit.
In developing CardioActive, the team used the Metacognitive Model, a theory developed by Co-Chief Investigator Professor Adrian Wells at the University of Manchester. They also worked with service users and their parents to develop the programme and make sure it met their needs.
“When developing an intervention that supports psychological growth as well as physical health a good starting point is to think about normal adjustment and what theory can tell us. We used the theory behind metacognitive therapy to help us talk about, frame and use physical activity in new and helpful ways with young people" says Professor Wells.
CardioActive commenced in March 2024, comparing the CardioActive programme to treatment as usual. The team worked with Manchester University NHS Foundation Trust (MFT) to identify potential participants aged 11 – 16 years old, who would be randomised so that 50% received the CardioActive treatment, and 50% continued with the standard treatment.
“I’d really like to thank all of the patients and their families who agreed to take part in CardioActive, they’re truly making a difference on improving the lives and futures of young people with a heart conditions.” Dr Capobianco continues. “It can be a real challenge for clinical teams to find the time to take part in and to deliver research amongst their busy clinical schedules.
"The Cardiology Department at MFT went above and beyond to support this project, and we owe a big thank you to them for their dedication and contribution to the project. It just goes to highlight the importance of cross-trust collaborations in research, especially those that bridge the gap between mental health and physical health.”
The target number of participants was 100, which the study team achieved last month. “We’re delighted to have recruited our 100th participant to the CardioActive study, it’s a major milestone for a study to recruit to target, as study recruitment is one of the most challenging parts of research delivery.”
Now that the 100 participants target has been reached, what is next for the research? “We will continue collecting follow-up surveys from patients until October 2025 and then begin to analyse our data. We look forward to sharing the outcomes and next steps of the study.”
CardioActive is funded by the National Institute for Health and Care Research (NIHR) as a Research for Patient Benefit study. You can find out more about the CardioActive study by visiting www.tinyurl.com/cardioactive-gmmh. If you’re interested in seeing what studies GMMH is a part of, or how you might be able to get involved, visit www.gmmh.nhs.uk/research-innovation.
References:
1. British Heart Foundation (2022, August). Global Heart and Circulatory Diseases Factsheet. UK Government. https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics-global-factsheet.pdf
2. B. Latal, S. Helfricht, J. E. Fischer, U. Bauersfeld, and M. A. Landolt, “Psychological adjustment and quality of life in children and adolescents following open-heart surgery for congenital heart disease: a systematic review,” BMC Pediatr, vol. 9, no. 1, Jan. 2009, doi: 10.1186/1471-2431-9-6.
