iP2P Mentorship Program for Teen HF Patients

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Behavioral: iPeer2Peer Program

• Registration Number: NCT05709132
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-01
• Study Start: 2024-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2027-04-13
• Study Completion: 2027-04-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPeer2Peer Program	iPeer2Peer Program	-

Primary Outcome Measures

Name	Time	Method
Acceptability (Mentees)	15 weeks after baseline/immediately after the intervention	Whether the innovation is agreeable, palatable or satisfactory
Feasibility (Mentees)	Baseline to 12 weeks post-program completion	The extent to which an innovation can be used or carried out successfully in a given setting
Feasibility (Mentors)	Baseline to study completion, an average of 1 year	The extent to which an innovation can be used or carried out successfully in a given setting
Appropriateness (Mentees)	Baseline to 12 weeks post-program completion	The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Level of engagement (Mentees)	15 weeks after baseline/immediately after the intervention
Appropriateness (Mentors)	Baseline to study completion, an average of 1 year	The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Level of engagement (Mentors)	Study completion, an average of 1 year
Acceptability (Mentors)	Study completion, an average of 1 year	Whether the innovation is agreeable, palatable or satisfactory
Adoption (Mentees)	Baseline to 12 weeks post-program completion	The intention, initial decision or action to try or use an innovation
Adoption (Mentors)	Baseline to study completion, an average of 1 year	The intention, initial decision or action to try or use an innovation

Secondary Outcome Measures

Name	Time	Method
Resiliency (Mentees)	Baseline to 12 weeks post-program completion
Disease self-management skills (Mentees)	Baseline to 12 weeks post-program completion
Emotional distress (Mentees)	Baseline to 12 weeks post-program completion
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
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
Adherence (Mentees)	Baseline to 12 weeks post-program completion	Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale
Perceived social support (Mentees)	Baseline to 12 weeks post-program completion
Quality of life (Mentees)	Baseline to 12 weeks post-program completion

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada