A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition

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 personalised lifestyle consideration guide and participation in a 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 4 consecutive group sessions and feedback from each session will be used to co-design and refine the intervention model for a definitive clinical trial.

Conditions

• Inherited Cardiac Conduction Disorder
• Cardiomyopathies

Interventions

BEHAVIORAL

PISICC

PISICC consists of: 1. Standard disease-specific information leaflet 2. Personalised lifestyle consideration form 3. 1-hour group session with up to 10 participants facilitated by the PhD student who is also an experienced cardiac genetic nurse. This will include discussions of 2 scenarios (communicating with clinicians and communicating with family) and a question and answer session based on the personalised lifestyle consideration form Components a) and b) will be given to the patient after the baseline assessment and there will be an interval of 2 weeks before the participants attend for component c).

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• King's College Hospital NHS Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• King's College London

  lead OTHER

Principal Investigators

• Christine Patch, PhD · King's College London

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2023-06-30

Completion

2024-06-30

Countries

• United Kingdom

Study Locations