xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968521</url>
    </required_header>
    <id_info>
      <org_study_id>X638s</org_study_id>
      <nct_id>NCT05968521</nct_id>
    </id_info>
    <brief_title>Cardiac Rehabilitation for Young People</brief_title>
    <acronym>CardioActive</acronym>
    <official_title>Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Greater Manchester Mental Health NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute for Health Research, United Kingdom</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Manchester</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of York</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Greater Manchester Mental Health NHS Foundation Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Heart problems are amongst the most common physical illnesses in children and young people&#xD;
        (CYP). They can be present from birth or develop as CYP get older and are linked to increased&#xD;
        physical and psychological difficulties overprotection from caregivers and healthcare&#xD;
        providers and reduced quality of life.&#xD;
  &#xD;
        While adults are offered exercise classes and lifestyle advice after a heart problem, CYP&#xD;
        with heart problems are not. Improving health behaviours in people with heart problems is&#xD;
        vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes).&#xD;
  &#xD;
        Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also&#xD;
        important to support their mental health. One way to do this is to develop and test the&#xD;
        acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of&#xD;
        exercise with mental health support for CYP.&#xD;
  &#xD;
        The aim is to develop and test the feasibility and acceptability of a trial of a cardiac&#xD;
        rehabilitation programme for CYP.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study is a single blind parallel randomised feasibility trial comparing a CR programme against usual care with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Blinding of allocation will be maintained for the principal investigator's, statistician, and quantitative research assistant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment Rate (Feasibility Outcome)</measure>
      <time_frame>Date of Baseline Assessment to end of follow-up (24 week follow up)</time_frame>
      <description>Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention Rate (Feasibility Outcome)</measure>
      <time_frame>Date of Baseline Assessment to end of follow-up (24 week follow up)</time_frame>
      <description>Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Attendance (Feasibility Outcome)</measure>
      <time_frame>Date of Baseline Assessment to end of follow-up (24 week follow up)</time_frame>
      <description>Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the Intervention</measure>
      <time_frame>Date of Baseline Assessment to end of follow-up (24 week follow up)</time_frame>
      <description>Acceptability of the intervention will be assessed in qualitative semi-structured interviews with children and young people, caregivers, and healthcare professionals, which will assess individuals views on the intervention, targets for improvement, and perceived acceptability of the components of the cardiac rehabilitation programme.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Strength and Difficulties Questionnaire (SDQ)</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The SDQ measures psychological wellbeing across five subscales: emotion, hyperactivity, conduct, peer relations and pro-social behaviour. The SDQ can be completed by CYP and caregivers.&#xD;
  Score for the subscales range from 0-10, with a total difficulties score (0-40) generated by summing together the scores from all subscales except the pro-social subscale. Higher scores on the pro-social scale reflect strengths whereas higher scores across other subscales reflect difficulties.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Paediatric Quality of Life (PedsQol)</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The PedsQol is a 23 item measures of health related quality of life, and includes four subscales: physical, emotional, social and school functioning. The questionnaire is commonly used in paediatric cardiology. The PedsQol will be completed by CYP.&#xD;
  The items are scores from 0 (Never) to 4 (Almost always). Total scores range from 0-100, with higher scores indicating better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six minute walk test (6MWT)</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The 6MWT is used to assess aerobic capacity and endurance. Performance on the 6MWT has been predictive of morbidity and mortality whereby poorer performance is associated with increased mortality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incremental Shuttle Walk Test (ISWT)</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The ISWT is used to measure maximal exercise capacity. The ISWT is a 12-level test (1 min at each level), whereby participants walk up and down a 10, course with increasing accelearion of 0.17 m/s up to a maximum speed of 2.37 m/s. Walking speed is dicated by an audio signal. The test ends when the subject has a heart rate greater than 85% of their predicted maximum, is limited by dyspnoea or when the participant is unable to maintain the required speed and doe snot complete a shuttle for second consecutive time. The distance covered from the number of shuttles will be calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Monitoring</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>Participants will wear an accelerometer (Actigraph) for 5 days to monitor physical activity levels at each assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metacognition Questionnaire-Adolescent (MCQ-A)</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The MCQ-A assesses metacognitive beliefs (beliefs about thinking) across five subscales (uncontrollability of worry, need to control thoughts, cognitive self-consciousness, positive beliefs about worry, and cognitive confidence). The measure contains 30 items and is scored on a likert scale from 1 (do not agree) to 4 (agree very much). Total scores range from 30-120 and 6 to 30 for each subscale. Greater scores indicate greater maladaptive metacognitive beliefs.&#xD;
  The measure and will be completed by CYP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child Health Utility-9D (CHU-9D)</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The CHU-9D measures quality of life using nine dimensions (worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, and ability to join in activities). Each item has 5 levels ranging from no problems to inability to do the item. Responses will be used to generate utility values in the health economic evaluation. The CHU-9D will be completed by CYP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health and Social Care Service-Use Questionnaire</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The questionnaire will include questions about whether the child has used any primary, secondary, or community-based health and social care and how often they used the service in the last 16 weeks (baseline study visit) or since the last assessment (follow-up study visits). The questionnaire will be developed from existing child relevant service use questionnaires held by the co-applicants and through discussion with the patient and public involvement representative, parent advisory group and clinical members of the study team. This will be completed by parents/primary caregivers. The responses given and the patient feedback will be used to further refine the health-resource use questionnaire ahead of the definitive study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographics Questionnaire</measure>
      <time_frame>Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)</time_frame>
      <description>The demographics questionnaire will collect variables such as participants age, sex, weight, height, BMI, type of heart problem, comorbid mental and physical illnesses, ethnicity, medication, socioeconomic status, parental occupational status. This will be completed by the parents/primary caregivers.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Congenital Heart Disease</condition>
    <condition>Cardiomyopathies</condition>
    <condition>Cardiac Arrythmias</condition>
    <condition>Heart Failure</condition>
    <condition>Cerebrovascular Event</condition>
    <condition>Heart Valve Diseases</condition>
    <arm_group>
      <arm_group_label>Cardiac Rehabilitation (Intervention)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as usual (Control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants allocated to the control group will receive treatment as usual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cardiac Rehabilitation (CR): Experimental</intervention_name>
      <description>CR will consist of six sessions lasting 90 minutes of a structured exercise programme, educational and lifestyle modules, and a psychological component. Sessions include group discussions, experiential learning and homework tasks that participants are asked to complete between sessions. Participants in this treatment arm will also receive routine clinical outpatient management alongside CR.</description>
      <arm_group_label>Cardiac Rehabilitation (Intervention)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as usual: Control</intervention_name>
      <description>Treatment as usual will include routine clinical outpatient management.</description>
      <arm_group_label>Treatment as usual (Control)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          All participants meeting the following inclusion criteria and aged between 11-16 years old&#xD;
          will be eligible:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Fluent in English&#xD;
  &#xD;
            2. Consent to participate&#xD;
  &#xD;
            3. Diagnosed with at least one of the following:&#xD;
  &#xD;
                 -  Congenital heart disease (all subtypes)&#xD;
  &#xD;
                 -  Cardiomyopathy&#xD;
  &#xD;
                 -  Cardiac arrhythmia&#xD;
  &#xD;
                 -  Heart failure&#xD;
  &#xD;
                 -  Post-cerebrovascular event&#xD;
  &#xD;
                 -  Post-heart valve repair/replacement&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Significant risk or safeguarding concerns (i.e., suicidal ideation)&#xD;
  &#xD;
            2. Head injury/organic impairment&#xD;
  &#xD;
            3. Significant social and/or communication difficulties&#xD;
  &#xD;
          Those with a formal diagnosis or under assessment for any above exclusion criteria will be&#xD;
          excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lora Capobianco, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Greater Manchester Mental Health Foundation Trust</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Adrian Wells, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manchester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lora Capobianco, PhD</last_name>
      <phone>01610046664</phone>
      <email>lora.capobianco@gmmh.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Adrian Wells, PhD</last_name>
      <phone>01612765399</phone>
      <email>adrian.wells@manchester.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Manchester University NHS Foundation Trust</name>
        <address>
          <city>Manchester</city>
          <zip>M13 9WL</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Lora Capobianco, PhD</last_name>
        <phone>01612710724</phone>
        <email>lora.capobianco@gmmh.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Lora Capobianco, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Greater Manchester Mental Health NHS Foundation Trust</investigator_affiliation>
      <investigator_full_name>Lora Capobianco</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Cardiac Rehabilitation</keyword>
    <keyword>Metacognitive Therapy</keyword>
    <keyword>Mental health</keyword>
    <keyword>Feasibility</keyword>
    <keyword>Congenital Heart Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Arrhythmias, Cardiac</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
      <mesh_term>Heart Valve Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968521
  org study id: X638s
  nct id: NCT05968521
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Heart problems are amongst the most common physical illnesses in children and young people
        (CYP). They can be present from birth or develop as CYP get older and are linked to increased
        physical and psychological difficulties overprotection from caregivers and healthcare
        providers and reduced quality of life.
  
        While adults are offered exercise classes and lifestyle advice after a heart problem, CYP
        with heart problems are not. Improving health behaviours in people with heart problems is
        vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes).
  
        Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also
        important to support their mental health. One way to do this is to develop and test the
        acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of
        exercise with mental health support for CYP.
  
        The aim is to develop and test the feasibility and acceptability of a trial of a cardiac
        rehabilitation programme for CYP.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study is a single blind parallel randomised feasibility trial comparing a CR programme against usual care with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition.
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: Blinding of allocation will be maintained for the principal investigator's, statistician, and quantitative research assistant.
  measure: Recruitment Rate (Feasibility Outcome)
  time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
  description: Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).
  measure: Retention Rate (Feasibility Outcome)
  time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
  description: Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)
  measure: Intervention Attendance (Feasibility Outcome)
  time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
  description: Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).
  measure: Acceptability of the Intervention
  time frame: Date of Baseline Assessment to end of follow-up (24 week follow up)
  description: Acceptability of the intervention will be assessed in qualitative semi-structured interviews with children and young people, caregivers, and healthcare professionals, which will assess individuals views on the intervention, targets for improvement, and perceived acceptability of the components of the cardiac rehabilitation programme.
  measure: Strength and Difficulties Questionnaire (SDQ)
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The SDQ measures psychological wellbeing across five subscales: emotion, hyperactivity, conduct, peer relations and pro-social behaviour. The SDQ can be completed by CYP and caregivers.
  Score for the subscales range from 0-10, with a total difficulties score (0-40) generated by summing together the scores from all subscales except the pro-social subscale. Higher scores on the pro-social scale reflect strengths whereas higher scores across other subscales reflect difficulties.
  measure: Paediatric Quality of Life (PedsQol)
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The PedsQol is a 23 item measures of health related quality of life, and includes four subscales: physical, emotional, social and school functioning. The questionnaire is commonly used in paediatric cardiology. The PedsQol will be completed by CYP.
  The items are scores from 0 (Never) to 4 (Almost always). Total scores range from 0-100, with higher scores indicating better quality of life.
  measure: Six minute walk test (6MWT)
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The 6MWT is used to assess aerobic capacity and endurance. Performance on the 6MWT has been predictive of morbidity and mortality whereby poorer performance is associated with increased mortality.
  measure: Incremental Shuttle Walk Test (ISWT)
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The ISWT is used to measure maximal exercise capacity. The ISWT is a 12-level test (1 min at each level), whereby participants walk up and down a 10, course with increasing accelearion of 0.17 m/s up to a maximum speed of 2.37 m/s. Walking speed is dicated by an audio signal. The test ends when the subject has a heart rate greater than 85% of their predicted maximum, is limited by dyspnoea or when the participant is unable to maintain the required speed and doe snot complete a shuttle for second consecutive time. The distance covered from the number of shuttles will be calculated.
  measure: Physical Activity Monitoring
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: Participants will wear an accelerometer (Actigraph) for 5 days to monitor physical activity levels at each assessment.
  measure: Metacognition Questionnaire-Adolescent (MCQ-A)
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The MCQ-A assesses metacognitive beliefs (beliefs about thinking) across five subscales (uncontrollability of worry, need to control thoughts, cognitive self-consciousness, positive beliefs about worry, and cognitive confidence). The measure contains 30 items and is scored on a likert scale from 1 (do not agree) to 4 (agree very much). Total scores range from 30-120 and 6 to 30 for each subscale. Greater scores indicate greater maladaptive metacognitive beliefs.
  The measure and will be completed by CYP.
  measure: Child Health Utility-9D (CHU-9D)
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The CHU-9D measures quality of life using nine dimensions (worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, and ability to join in activities). Each item has 5 levels ranging from no problems to inability to do the item. Responses will be used to generate utility values in the health economic evaluation. The CHU-9D will be completed by CYP.
  measure: Health and Social Care Service-Use Questionnaire
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The questionnaire will include questions about whether the child has used any primary, secondary, or community-based health and social care and how often they used the service in the last 16 weeks (baseline study visit) or since the last assessment (follow-up study visits). The questionnaire will be developed from existing child relevant service use questionnaires held by the co-applicants and through discussion with the patient and public involvement representative, parent advisory group and clinical members of the study team. This will be completed by parents/primary caregivers. The responses given and the patient feedback will be used to further refine the health-resource use questionnaire ahead of the definitive study.
  measure: Demographics Questionnaire
  time frame: Baseline, 12 weeks (end of treatment), and 24 weeks (follow-up)
  description: The demographics questionnaire will collect variables such as participants age, sex, weight, height, BMI, type of heart problem, comorbid mental and physical illnesses, ethnicity, medication, socioeconomic status, parental occupational status. This will be completed by the parents/primary caregivers.
  arm group label: Cardiac Rehabilitation (Intervention)
  arm group type: Experimental
  description: Participants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component.
  arm group label: Treatment as usual (Control)
  arm group type: Active Comparator
  description: Participants allocated to the control group will receive treatment as usual.
  intervention type: Behavioral
  intervention name: Cardiac Rehabilitation (CR): Experimental
  description: CR will consist of six sessions lasting 90 minutes of a structured exercise programme, educational and lifestyle modules, and a psychological component. Sessions include group discussions, experiential learning and homework tasks that participants are asked to complete between sessions. Participants in this treatment arm will also receive routine clinical outpatient management alongside CR.
  arm group label: Cardiac Rehabilitation (Intervention)
  intervention type: Behavioral
  intervention name: Treatment as usual: Control
  description: Treatment as usual will include routine clinical outpatient management.
  arm group label: Treatment as usual (Control)
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Lora Capobianco, PhD
  role: Principal Investigator
  affiliation: Greater Manchester Mental Health Foundation Trust
  last name: Adrian Wells, PhD
  role: Principal Investigator
  affiliation: University of Manchester
  last name: Lora Capobianco, PhD
  phone: 01610046664
  email: lora.capobianco@gmmh.nhs.uk
  last name: Adrian Wells, PhD
  phone: 01612765399
  email: adrian.wells@manchester.ac.uk
  facility: 
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Greater Manchester Mental Health NHS Foundation Trust
  investigator full name: Lora Capobianco
  investigator title: Principal Investigator
  mesh term: Heart Diseases
  mesh term: Cardiomyopathies
  mesh term: Arrhythmias, Cardiac
  mesh term: Heart Defects, Congenital
  mesh term: Heart Valve Diseases