The iPeer2Peer Mentorship Program for Young Adults With Heart Disease

NCT ID: NCT07119216

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-12-31

Brief Summary

Young adults with heart failure, including those who have undergone a heart transplant, experience considerable psychosocial stressors associated with living with a chronic illness, including heightened levels of anxiety and depression, and poor health-related quality of life compared to 'healthy' peers. Psychosocial challenges during young adulthood are especially concerning as this life stage represents a unique transitional period for fostering self-identity, friendships, mastery, and decision-making competencies. As young people with heart failure transition into adult healthcare systems, they take on greater personal responsibility due to their increasing independence and involvement in care decisions, and require more support and resources to live longer, healthier lives. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare.

An established, online mentorship program, iPeer2Peer (iP2P), will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across five sites. Sixty mentees will be recruited and randomized into intervention and control groups. Thirty mentees in the intervention group will be matched 1:1 with 20 trained mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.

Detailed Description

Primary Objective: to evaluate the feasibility of the iP2P program in terms of participant: (a) recruitment and withdrawal rates, (b) adherence with the program, (c) perceptions regarding the acceptability and level of engagement in the iP2P program, and (d) perceptions of barriers and enablers of the iP2P program.

Secondary Objective: to explore the iP2P program's impact on preliminary psychosocial outcomes in:

i.Mentees- (a) disease self-management, (b) perceived social support, (c) emotional distress, (d) resiliency and (e) hope; ii.Mentors- (a) perceived social role satisfaction, (b) emotional distress, and (c) hope.

A waitlist pilot RCT allows for an effective comparison of the study intervention with a control group receiving standard of care while not disadvantaging the control group who will have the option of participating in the intervention following the completion of the trial.

Up to 80 participants will be enrolled in this study at five sites: Mazankowski Alberta Heart Institute (Edmonton), St. Boniface Hospital (Winnipeg), Toronto General Hospital (Toronto), the University of British Columbia Division of Cardiology - Vancouver General Hospital and St Paul's Hospital (Vancouver).

We expect 20 adult mentors and 60 young adult mentees will be enrolled across these sites, with 4-6 mentors and about 10-15 mentees per site. The mentees will be randomized to the experimental (iP2P program; n=30) or control (waitlist; n=30) group. Mentees assigned to the waitlist will receive the iP2P program once all outcome measures are complete.

All mentees will be asked to participate in semi-structured individual interviews at baseline (ME T1) and and all mentees in the intervention group will be asked to participate in semi-structured interviews at 12 weeks - immediately post-intervention (ME T2). Interviews will be conducted by an interviewer trained in qualitative methods by telephone, in-person or virtually via the PHIPA-compliant version of Zoom or Microsoft Teams (depending on participants' preference), at a time that is convenient for the participant. Interviews will be guided by a semi-structured interview guide. ME T1 interviews will aim to assess motivations for participation, hopes and expectations, and preferences around mentor characteristics; and ME T2 interviews will aim to assess the primary outcomes evaluating feasibility.

All mentors will be asked to participate in a focus group/semi-structured interview prior to mentor training (MR T1) and study end (MR T2). MR T1 focus groups/interviews will aim to assess motivations for participation and hopes and expectations, and MR T2 focus groups/interviews will aim to assess the primary outcomes evaluating feasibility. Focus groups/interviews will be conducted by an interviewer trained in qualitative methods. Focus groups/interviews will be conducted on a mutually agreed upon date and over the internet via a web-based video communication program (e.g., PHIPA-compliant version of Zoom or Microsoft Teams).

The semi-structured individual interviews and focus groups will be audiotaped, transcribed and analyzed using qualitative descriptive approach using thematic and content analysis.

Conditions

Heart Failure; Mentorship; Peer Support; Peer Support and Chronic Disease; Young Adults; Cardiomyopathies; Heart Transplant Recipient; Fontan Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

In addition to their standard medical care, mentees in the experimental group will receive mentorship and support via the iP2P program. Trained mentors will provide information and support to mentee participants to encourage participation in self-management skill-building tailored to their needs. Each mentor will work with no more than two mentees at once for the study. Efforts will be made to pair mentors and mentees who share similar characteristics (e.g., similar disease severity, symptom profile, treatment regimen experiences, caregiver role, sex/gender, geographic area of residence). To ensure safety, a member of the research team will monitor all calls and messaging conversations as well as intervene in any potential safety concerns (e.g., discussion of suicidal ideation) or inappropriate behavior (e.g. bullying).

Group Type: EXPERIMENTAL

Peer Mentorship

Intervention Type: BEHAVIORAL

The iPeer2Peer intervention is a peer support mentorship program that will provide modelling and reinforcement by pre-screened and trained peer mentors to the mentees. The mentorship program will encourage mentees to develop and engage in self-management and transition skills and support the participants; practice of these skills. The mentors will provide information and support to mentee participants via 5-10 calls (using WhatsApp) of 20-30 minute durations and text messaging (using WhatsApp) for 12 weeks to encourage participation in self-management skill building tailored to their needs.

Waitlist control

The control group will receive standard care without the iP2P intervention. The control group will be offered the iP2P intervention after completion of all outcome measures for a period of 12 weeks with the same research team support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer Mentorship

The iPeer2Peer intervention is a peer support mentorship program that will provide modelling and reinforcement by pre-screened and trained peer mentors to the mentees. The mentorship program will encourage mentees to develop and engage in self-management and transition skills and support the participants; practice of these skills. The mentors will provide information and support to mentee participants via 5-10 calls (using WhatsApp) of 20-30 minute durations and text messaging (using WhatsApp) for 12 weeks to encourage participation in self-management skill building tailored to their needs.

Intervention Type: BEHAVIORAL

Other Intervention Names

Peer mentoring; Peer support

Eligibility Criteria

Inclusion Criteria

Heart disease patients include:

• Patients with any past or present heart failure
• Patients with cardiomyopathy seen at least 2 times a year
• Patients who have undergone a Fontan procedure
• Patients who have undergone a heart transplant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Samantha Anthony

OTHER

Sponsor Role: lead

Responsible Party

Samantha Anthony

Health Clinician Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Samantha Anthony

Role: CONTACT

samantha.anthony@sickkids.ca

416-813-7654 ext. 303126

Facility Contacts

Samantha Anthony

Role: primary

samantha.anthony@sickkids.ca

416-813-7654 ext. 303126

Other Identifiers

G-24-0036451

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CTO5006

Identifier Type: -

Identifier Source: org_study_id