A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition

NCT03602040 | Suspended

• 3 other identifiers: 249303ICA-CDRF-2015-01-046GFWKBQR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Engagement of clinical staff with identification of patients

  Number of participants identified for recruitment

  3 months

• Engagement of participants with recruitment procedures

  Number of participants consented, number of participants declined and withdrawn

  3 months

• Completion of data collection

  Rates of data collection at baseline and follow-up, and reasons for missing data

  3 months

• Engagement with psychoeducational intervention

  Rates of intervention uptake and reasons for dropout

  3 months

Secondary Outcomes (4)

• Perceived Competence Scale

  Measured at baseline and 3 months post intervention

• Perceived Choice and Awareness of Self Scale

  Measured at baseline and 3 months post intervention

• Health Care Climate Questionnaire

  Measured at baseline and 3 months post intervention

• Heart-related Anxiety (Questionnaire)

  Measured at baseline and 3 months post intervention

Other Outcomes (1)

• Process evaluation (Qualitative interviews)

  3 months

Study Arms (1)

PISICC group

EXPERIMENTAL

Psychoeducational intervention

Behavioral: PISICC

Interventions

PISICC 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).

PISICC group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are aged 16 and older.
• 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.

You may not qualify if:

• Patients who were initially referred to the clinic for reasons other than cardiac screening and/or predictive genetic testing for ICCs.
• 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.
• Patients who have undergone cardiac screening and/or predictive genetic testing for ICCs and have received a negative result.
• Patients below 16 years of age.
• Patients with insufficient command of written and spoken English to comprehend study documents and participate in the study procedures and discussion.
• Patients who are already participating in a study involving a psychoeducational intervention, novel cardiac medication or device.

Sponsors & Collaborators

• King's College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• King's College Hospital NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christine Patch, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This feasibility study will be using mixed methods and will be conducted in 2 phases.Phase 1 of the study is an uncontrolled clinical trial of the psychoeducational education. Phase 2 is a nested qualitative component of the feasibility study and will be comprise of at least 7 semi-structured interviews lasting up to 30 minutes with patients who participated in the trial.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 26, 2018
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

GB (1)