A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition

NCT ID: NCT03602040

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PISICC group

Psychoeducational intervention

Group Type: EXPERIMENTAL

PISICC

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients who are aged 16 and older.

2. Patients who have undergone cardiac screening and/or predictive genetic testing for inherited cardiac conditions and are within 6 months of receiving a new diagnosis of an inherited cardiac condition (ICC) and/or have been found to be carriers of a genetic alteration that can cause an ICC.

Exclusion Criteria

1. Patients who were initially referred to the clinic for reasons other than cardiac screening and/or predictive genetic testing for ICCs.

2. Patients who have undergone cardiac screening and/or predictive genetic testing for ICCs and more than 6 months have passed since receiving a new diagnosis of an ICC and/or a carrier result for a genetic alteration that can cause an ICC.

3. Patients who have undergone cardiac screening and/or predictive genetic testing for ICCs and have received a negative result.

4. Patients below 16 years of age.

5. Patients with insufficient command of written and spoken English to comprehend study documents and participate in the study procedures and discussion.

6. Patients who are already participating in a study involving a psychoeducational intervention, novel cardiac medication or device.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Patch, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

King's College Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

ICA-CDRF-2015-01-046

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GFWKBQR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

249303

Identifier Type: -

Identifier Source: org_study_id