Clinical trial NCT03602040: A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition
Official title: A Psychoeducational Intervention Supporting Patients With a New Diagnosis and/or Genetic Carrier Status for an Inherited Cardiac Condition-a Feasibility Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Inherited Cardiac Conduction Disorder
Cardiomyopathies
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: King's College Hospital NHS Trust
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2018-07-26
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Engagement of clinical staff with identification of patients
timeFrame: 3 months
measure: Engagement of participants with recruitment procedures
timeFrame: 3 months
measure: Completion of data collection
timeFrame: 3 months
measure: Engagement with psychoeducational intervention
timeFrame: 3 months
Secondary outcomes:
measure: Perceived Competence Scale
timeFrame: Measured at baseline and 3 months post intervention
measure: Perceived Choice and Awareness of Self Scale
timeFrame: Measured at baseline and 3 months post intervention
measure: Health Care Climate Questionnaire
timeFrame: Measured at baseline and 3 months post intervention
measure: Heart-related Anxiety (Questionnaire)
timeFrame: Measured at baseline and 3 months post intervention
Other outcomes:
measure: Process evaluation (Qualitative interviews)
timeFrame: 3 months
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: Christine Patch, PhD
role: PRINCIPAL_INVESTIGATOR
References: