Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-01 @ 4:59 AM
Study NCT ID:
NCT05709132
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iP2P Mentorship Program for Adolescent HF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Quasi-experimental single arm pre-post study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability (Mentees)', 'timeFrame': '15 weeks after baseline/immediately after the intervention', 'description': 'Whether the innovation is agreeable, palatable or satisfactory'}, {'measure': 'Acceptability (Mentors)', 'timeFrame': 'Study completion, an average of 1 year', 'description': 'Whether the innovation is agreeable, palatable or satisfactory'}, {'measure': 'Adoption (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion', 'description': 'The intention, initial decision or action to try or use an innovation'}, {'measure': 'Adoption (Mentors)', 'timeFrame': 'Baseline to study completion, an average of 1 year', 'description': 'The intention, initial decision or action to try or use an innovation'}, {'measure': 'Feasibility (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion', 'description': 'The extent to which an innovation can be used or carried out successfully in a given setting'}, {'measure': 'Feasibility (Mentors)', 'timeFrame': 'Baseline to study completion, an average of 1 year', 'description': 'The extent to which an innovation can be used or carried out successfully in a given setting'}, {'measure': 'Appropriateness (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion', 'description': 'The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem'}, {'measure': 'Appropriateness (Mentors)', 'timeFrame': 'Baseline to study completion, an average of 1 year', 'description': 'The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem'}, {'measure': 'Level of engagement (Mentees)', 'timeFrame': '15 weeks after baseline/immediately after the intervention'}, {'measure': 'Level of engagement (Mentors)', 'timeFrame': 'Study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Disease self-management skills (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion'}, {'measure': 'Adherence (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion', 'description': 'Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale'}, {'measure': 'Quality of life (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion'}, {'measure': 'Perceived social support (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion'}, {'measure': 'Emotional distress (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion'}, {'measure': 'Resiliency (Mentees)', 'timeFrame': 'Baseline to 12 weeks post-program completion'}, {'measure': 'Assessment of mentor quality (Mentees)', 'timeFrame': '15 weeks after baseline/immediately after the intervention'}, {'measure': 'Physical and emotional symptoms (Mentors)', 'timeFrame': 'Baseline to study completion, an average of 1 year'}, {'measure': 'Perceived social role satisfaction (Mentors)', 'timeFrame': 'Baseline to study completion, an average of 1 year'}, {'measure': 'Self-efficacy (Mentors)', 'timeFrame': 'Baseline to study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peer Support Mentorship', 'Pediatrics', 'Adherence', 'Cardiomyopathy'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The iPeer2Peer (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A quasi-experimental single-arm pre-post study design will be employed across three sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-30 years of age) who will undergo training in mentoring and the use of eHealth technology. Mentor-mentee pairings will connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills. Data will be collected using standardized instruments and interviews across three time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Mentee inclusion criteria:\n\n1. patient with a cardiac diagnosis,\n2. at least 4 months post-diagnosis,\n3. between the ages of 12 and 17 years,\n4. able to speak and read English, and\n5. willingness to commit to 5-10 texts and/or calls of 20-30 minutes each with a peer mentor over a period of 15 weeks.\n\nMentor inclusion criteria:\n\n1. patient with a cardiac diagnosis,\n2. between the ages of 18 and 30 years,\n3. able to speak and read English,\n4. nominated by a member of their health care team as a good mentor based on maturity and emotional stability,\n5. willingness to commit to peer mentor training (20 hours) via the PHIPA-compliant version of Zoom or Microsoft Teams and mentoring adolescent participants (once paired with mentee, 5-10 texts and/or calls of 20-30 minutes over a period of 15 weeks),\n6. good communication skills (as assessed by a healthcare provider), and\n7. previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset.\n\nExclusion Criteria:\n\n1. significant cognitive impairments as assessed by a qualified healthcare provider,\n2. a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart failure care regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and\n3. participating in other peer support or self-management interventions.'}, 'identificationModule': {'nctId': 'NCT05709132', 'acronym': 'iP2P HF', 'briefTitle': 'iP2P Mentorship Program for Adolescent HF Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Function Patients', 'orgStudyIdInfo': {'id': '1000080204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iPeer2Peer Program', 'description': 'Participates in the iPeer2Peer program', 'interventionNames': ['Behavioral: iPeer2Peer Program']}], 'interventions': [{'name': 'iPeer2Peer Program', 'type': 'BEHAVIORAL', 'description': 'Behavioral: iPeer2Peer Support Mentorship Program is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees.', 'armGroupLabels': ['iPeer2Peer Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Samantha J Anthony, PhD', 'role': 'CONTACT', 'email': 'samantha.anthony@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '303126'}, {'name': 'Samantha J Anthony, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Samantha J Anthony, PhD', 'role': 'CONTACT', 'email': 'samantha.anthony@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '303126'}, {'name': 'Sophie Bui, BHSc', 'role': 'CONTACT', 'email': 'sophie.bui@sickkids.ca'}], 'overallOfficials': [{'name': 'Samantha J Anthony, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Centre Hospitalier Universitaire Sainte-Justine', 'class': 'UNKNOWN'}, {'name': "University of Alberta/Stollery Children's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samantha Anthony', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}