Heart Failure Clinical Trial
— iP2P HFOfficial title:
Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Failure Patients
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 waitlist hybrid implementation-effectiveness type 3 pilot randomized controlled trial design will be employed across four sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-25 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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | April 13, 2027 |
Est. primary completion date | April 13, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | Mentee inclusion criteria: 1. heart failure patient, 2. at least 4 months post-diagnosis, 3. between the ages of 12 and 17 years, 4. able to speak and read English, and 5. 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. Mentor inclusion criteria: 1. heart failure patient, 2. between the ages of 18 and 25 years, 3. able to speak and read English, 4. nominated by a member of their health care team as a good mentor based on maturity and emotional stability, 5. 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), 6. good communication skills (as assessed by a healthcare provider), and 7. previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset. Exclusion Criteria: 1. significant cognitive impairments as assessed by a qualified healthcare provider, 2. 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 3. participating in other peer support or self-management interventions. |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | British Columbia Children's Hospital, The Centre Hospitalier Universitaire Sainte-Justine, University of Alberta/Stollery Children's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability (Mentees) | Whether the innovation is agreeable, palatable or satisfactory | 15 weeks after baseline/immediately after the intervention | |
Primary | Acceptability (Mentors) | Whether the innovation is agreeable, palatable or satisfactory | Study completion, an average of 1 year | |
Primary | Adoption (Mentees) | The intention, initial decision or action to try or use an innovation | Baseline to 12 weeks post-program completion | |
Primary | Adoption (Mentors) | The intention, initial decision or action to try or use an innovation | Baseline to study completion, an average of 1 year | |
Primary | Feasibility (Mentees) | The extent to which an innovation can be used or carried out successfully in a given setting | Baseline to 12 weeks post-program completion | |
Primary | Feasibility (Mentors) | The extent to which an innovation can be used or carried out successfully in a given setting | Baseline to study completion, an average of 1 year | |
Primary | Appropriateness (Mentees) | The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem | Baseline to 12 weeks post-program completion | |
Primary | Appropriateness (Mentors) | The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem | Baseline to study completion, an average of 1 year | |
Primary | Level of engagement (Mentees) | 15 weeks after baseline/immediately after the intervention | ||
Primary | Level of engagement (Mentors) | Study completion, an average of 1 year | ||
Secondary | Disease self-management skills (Mentees) | Baseline to 12 weeks post-program completion | ||
Secondary | Adherence (Mentees) | Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale | Baseline to 12 weeks post-program completion | |
Secondary | Quality of life (Mentees) | Baseline to 12 weeks post-program completion | ||
Secondary | Perceived social support (Mentees) | Baseline to 12 weeks post-program completion | ||
Secondary | Emotional distress (Mentees) | Baseline to 12 weeks post-program completion | ||
Secondary | Resiliency (Mentees) | Baseline to 12 weeks post-program completion | ||
Secondary | Assessment of mentor quality (Mentees) | 15 weeks after baseline/immediately after the intervention | ||
Secondary | Physical and emotional symptoms (Mentors) | Baseline to study completion, an average of 1 year | ||
Secondary | Perceived social role satisfaction (Mentors) | Baseline to study completion, an average of 1 year | ||
Secondary | Self-efficacy (Mentors) | Baseline to study completion, an average of 1 year |
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