iP2P Mentorship Program for Teen HF Patients

Study Overview
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Brief Summary
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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.

Official Title
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Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: iPeer2Peer Program


Participation Criteria
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Eligibility Criteria
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Mentee inclusion criteria: heart failure patient, at least 4 months post-diagnosis, between the ages of 12 and 17 years, able to speak and read English, and 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: heart failure patient, between the ages of 18 and 25 years, able to speak and read English, nominated by a member of their health care team as a good mentor based on maturity and emotional stability, 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), good communication skills (as assessed by a healthcare provider), and previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset. Exclusion Criteria: significant cognitive impairments as assessed by a qualified healthcare provider, 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 participating in other peer support or self-management interventions.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Waitlist randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPeer2Peer Program<br> | Behavioral: iPeer2Peer Program<br>* Behavioral: iPeer2Peer Support Mentorship Program iPeer2Peer 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.<br>|
| No Intervention: Standard of Care Waitlist Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability (Mentees) | Whether the innovation is agreeable, palatable or satisfactory | 15 weeks after baseline/immediately after the intervention | 
| Acceptability (Mentors) | Whether the innovation is agreeable, palatable or satisfactory | Study completion, an average of 1 year | 
| Adoption (Mentees) | The intention, initial decision or action to try or use an innovation | Baseline to 12 weeks post-program completion | 
| Adoption (Mentors) | The intention, initial decision or action to try or use an innovation | Baseline to study completion, an average of 1 year | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Level of engagement (Mentees) |  | 15 weeks after baseline/immediately after the intervention | 
| Level of engagement (Mentors) |  | Study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease self-management skills (Mentees) |  | Baseline to 12 weeks post-program completion | 
| Adherence (Mentees) | Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale | Baseline to 12 weeks post-program completion | 
| Quality of life (Mentees) |  | Baseline to 12 weeks post-program completion | 
| Perceived social support (Mentees) |  | Baseline to 12 weeks post-program completion | 
| Emotional distress (Mentees) |  | Baseline to 12 weeks post-program completion | 
| Resiliency (Mentees) |  | Baseline to 12 weeks post-program completion | 
| Assessment of mentor quality (Mentees) |  | 15 weeks after baseline/immediately after the intervention | 
| Physical and emotional symptoms (Mentors) |  | Baseline to study completion, an average of 1 year | 
| Perceived social role satisfaction (Mentors) |  | Baseline to study completion, an average of 1 year | 
| Self-efficacy (Mentors) |  | Baseline to study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer Support Mentorship, Pediatrics, Adherence, Cardiomyopathy