Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-29 @ 8:18 PM
Study NCT ID:
NCT04271358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Coaching Intervention in Young Adults With Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2032-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate number of participants enrolled', 'timeFrame': 'Up to 2 months after recruitment closes', 'description': 'Evaluate the number of participants contacted about the study who actually enrolled'}, {'measure': 'Evaluate completion of study', 'timeFrame': 'Up to 8 months after enrollment of each participant', 'description': 'Determine the number of participants who enrolled in the study who completed it'}, {'measure': 'Measure impact on health', 'timeFrame': 'Up to 8 months after enrollment of each participant', 'description': 'Evaluate the number of participant who stated the intervention had a positive impact on their health'}, {'measure': 'Determine change in patient activation', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM)'}, {'measure': 'Determine change in self-management', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH)'}], 'secondaryOutcomes': [{'measure': 'Determine change in transition readiness', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ)'}, {'measure': 'Determine change in health related quality of life', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Determine the change in health related quality of life over 6 months as measured by the Short-From 12 (SF-12)'}, {'measure': 'Determine change in emotional health', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI)'}, {'measure': 'Evaluate successful transfer of participants from pediatric to adult cardiology care', 'timeFrame': 'up to 10 years', 'description': 'Evaluate number of participants that transfer from pediatric to adult cardiology care with at least consecutive visits 10 years post study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease', 'Congenital Heart Defect']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.', 'detailedDescription': 'Our research team has developed a peer coaching intervention that has been deployed to promote activated self-management for AYAs with several conditions, and this has been modified adolescents and young adults (AYA) with with congenital heart disease (CHD). This study will be conducted over two years and pair AYA with CHD with a peer coach who also has CHD has successfully navigated the transition to adult medical care and over six months will work to promote the motivation for self-care as well as the development of self-management skills. This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-26\n* Diagnosis of congenital heart disease\n* Patient at a Duke pediatric cardiology clinic\n* Access to a smart phone\n\nExclusion Criteria:\n\n* Cognitive delay\n* Patient at an adult cardiology clinic'}, 'identificationModule': {'nctId': 'NCT04271358', 'acronym': 'CHASM in ACHD', 'briefTitle': 'Peer Coaching Intervention in Young Adults With Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'Pro00103600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer Coaching', 'description': 'Participant receive a 6 month peer health coaching intervention.', 'interventionNames': ['Behavioral: Peer Health Coaching']}, {'type': 'NO_INTERVENTION', 'label': 'Education only', 'description': 'Participants receive education-only material (newsletter) biweekly for 6 months'}], 'interventions': [{'name': 'Peer Health Coaching', 'type': 'BEHAVIORAL', 'description': 'The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.', 'armGroupLabels': ['Peer Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Health', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Richard A Krasuski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Gary Maslow, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adult Congenital Heart Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}