PISICC feasibilty study v1
Research type
Research Study
Full title
A Psychoeducational Intervention Supporting patients with a new diagnosis and/or genetic carrier status for an Inherited Cardiac Condition-a feasibility study
IRAS ID
249303
Contact name
Teofila Bueser
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Inherited heart conditions (IHCs) can cause young sudden deaths due to a genetic trait that leads to a thickened heart muscle or abnormal heart rhythms. Relatives of an affected person have a 50% chance of inheriting IHCs and this is determined either through a blood test (predictive genetic test) and/or physical tests such as a heart tracing (electrocardiogram), scan (echocardiogram) and exercise test. When patients find out they are affected or are carriers for an IHC, they have numerous questions about medical management, prognosis, lifestyle; as well as experiencing stress and anxiety because of the impact on their health and risk to their family. Based on published studies and interviews, a psychoeducational intervention underpinned by Self-determination Theory was developed to support these patients
An uncontrolled study to determine the feasibility of the intervention and outcome measures will be undertaken. Patients with a new IHC diagnosis or a carrier result aged 16 years and older will be recruited from outpatient clinics in London and will be receive the intervention consisting of a disease-specific information leaflet, a lifestyle consideration guide and participation in one 1-hour group session facilitated by a cardiac genetic nurse. Outcome measures to look at degree of self-determination, autonomy support and competence; and heart-related anxiety will be collected at baseline and at 3 months post intervention. Clinical and socio-demographic data will be obtained from medical notes. The feasibility and acceptability of the intervention will be measured by assessment of the study procedures such as recruitment, retention and any adverse events. It is expected that there will be up to 3 group sessions and feedback from each session will be used to co-design and refine the intervention for a definitive clinical trial.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0263
Date of REC Opinion
24 Oct 2018
REC opinion
Further Information Favourable Opinion