Inherited Cardiac Conduction DisorderPISICCNCT03602040
A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition
A study testing PISICC in people with Inherited Cardiac Conduction Disorder and Cardiomyopathies, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inherited Cardiac Conduction Disorder, Cardiomyopathies
- What is being tested?
- PISICC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- PISICC
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PISICCBehavioural
PISICC consists of:
- Standard disease-specific information leaflet
- Personalised lifestyle consideration form
- 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).
| Study group | Role | What they receive |
|---|---|---|
| PISICC group | Experimental | Psychoeducational intervention Receives: Behavioral: PISICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement of clinical staff with identification of patients
Number of participants identified for recruitment
Measured: 3 months
Engagement of participants with recruitment procedures
Number of participants consented, number of participants declined and withdrawn
Measured: 3 months
Completion of data collection
Rates of data collection at baseline and follow-up, and reasons for missing data
Measured: 3 months
Engagement with psychoeducational intervention
Rates of intervention uptake and reasons for dropout
Measured: 3 months
Secondary outcomes (4)
Perceived Competence Scale
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: Measured at baseline and 3 months post intervention
Perceived Choice and Awareness of Self Scale
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: Measured at baseline and 3 months post intervention
Health Care Climate Questionnaire
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: Measured at baseline and 3 months post intervention
Heart-related Anxiety (Questionnaire)
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: Measured at baseline and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Awaiting advice from R\&D regarding recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Cardiac Conduction DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christine Patch, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602040
- Sponsor's protocol ID
- 249303
- Other IDs
- ICA-CDRF-2015-01-046, GFWKBQR
- Acronym
- PISICC
- Status last verified
- Feb 2021
- First submitted
- 26 Jun 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychoeducational Intervention Supporting Patients With a New Diagnosis and/or Genetic Carrier Status for an Inherited Cardiac Condition-a Feasibility Study
- ClinicalTrials.gov ID
- NCT03602040
- Acronym / sponsor ID
- PISICC / 249303
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting advice from R\&D regarding recruitment
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PISICC group | Experimental | Behavioral: PISICCPsychoeducational intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PISICCPISICC 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). | Behavioural | PISICC group |
Primary outcome
Engagement of clinical staff with identification of patients
Time frame: 3 months
Number of participants identified for recruitment
Engagement of participants with recruitment procedures
Time frame: 3 months
Number of participants consented, number of participants declined and withdrawn
Completion of data collection
Time frame: 3 months
Rates of data collection at baseline and follow-up, and reasons for missing data
Engagement with psychoeducational intervention
Time frame: 3 months
Rates of intervention uptake and reasons for dropout
4 secondary outcomes
Perceived Competence Scale
Time frame: 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
Health Care Climate Questionnaire
Time frame: Measured at baseline and 3 months post intervention
Heart-related Anxiety (Questionnaire)
Time frame: Measured at baseline and 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Patch, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PISICC in people with Inherited Cardiac Conduction Disorder and Cardiomyopathies, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement of clinical staff with identification of patients (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.