- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03602040
A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition (PISICC)
February 24, 2021 updated by: King's College London
A Psychoeducational Intervention Supporting Patients With a New Diagnosis and/or Genetic Carrier Status for an Inherited Cardiac Condition-a Feasibility Study
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.
Study Overview
Status
Suspended
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, SE5 9RS
- King's College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PISICC group
Psychoeducational intervention
|
PISICC consists of:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement of clinical staff with identification of patients
Time Frame: 3 months
|
Number of participants identified for recruitment
|
3 months
|
Engagement of participants with recruitment procedures
Time Frame: 3 months
|
Number of participants consented, number of participants declined and withdrawn
|
3 months
|
Completion of data collection
Time Frame: 3 months
|
Rates of data collection at baseline and follow-up, and reasons for missing data
|
3 months
|
Engagement with psychoeducational intervention
Time Frame: 3 months
|
Rates of intervention uptake and reasons for dropout
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Competence Scale
Time Frame: Measured at baseline and 3 months post intervention
|
A short 4-item questionnaire assessing feelings of competence about a specific domain.
In this case, this is for the management of the diagnosis or carrier status.
The score ranges from 28 (high perceived competence) to 4 (low perceived competence) Metric for summarising data: t-test
|
Measured at baseline and 3 months post intervention
|
Perceived Choice and Awareness of Self Scale
Time Frame: Measured at baseline and 3 months post intervention
|
A short, 10-item scale, with two 5-item subscales pertaining to perception of choice in one's actions and awareness of oneself.
The total score ranges from 50 (high perceived choice and awareness of self) to 10 (low perceived choice and awareness of self).
For the perceived choice subscale, the score ranges from 25 (high perceived choice) to 5 (low perceived choice).
For the perceived awareness of self subscale, the score ranges from 5 (high perceived awareness of self) to 1 (low perceived awareness of self) Metric for summarising data: t-test
|
Measured at baseline and 3 months post intervention
|
Health Care Climate Questionnaire
Time Frame: Measured at baseline and 3 months post intervention
|
A 15-item questionnaire to assess the patients' perception of the degree to which their health care team is supporting their autonomy. The average score ranges from 7 (high perceived autonomy support from clinicians) to 1 (low perceived autonomy support from clinicians). Metric for summarising data: t-test |
Measured at baseline and 3 months post intervention
|
Heart-related Anxiety (Questionnaire)
Time Frame: Measured at baseline and 3 months post intervention
|
Cardiac Anxiety Questionnaire-an 18-tem self-reported questionnaire designed to measure heart-focused anxiety.
The total score ranges from 72 (high heart-related anxiety) to 0 (low heart-related anxiety) Metric for summarising data: t-test
|
Measured at baseline and 3 months post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Process evaluation (Qualitative interviews)
Time Frame: 3 months
|
Nested qualitative component of the study consisting of semi-structured interviews with a subset of patients who participated in the study.
The topic guide will gather insights on the patient experience of the intervention and trial procedures.
All interviews will be digitally recorded, transcribed and thematic analysis will be facilitated by NVivo software.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Patch, PhD, King's College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2022
Primary Completion (ANTICIPATED)
June 1, 2023
Study Completion (ANTICIPATED)
June 1, 2024
Study Registration Dates
First Submitted
June 26, 2018
First Submitted That Met QC Criteria
July 25, 2018
First Posted (ACTUAL)
July 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 249303
- ICA-CDRF-2015-01-046 (OTHER_GRANT: National Institute for Health Research)
- GFWKBQR (OTHER_GRANT: Sponsor Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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