The iPeer2Peer Mentorship Program for Young Adults With Heart Disease

NCT07119216 | Not Yet Recruiting

• 2 other identifiers: CTO5006G-24-0036451
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

heart failure; mentorship; peer support; young adult; heart disease

Outcome Measures

Primary Outcomes (5)

• Recruitment and withdrawal rates

  (a) Recruitment rates (more than 70%) and withdrawal rates (less than 15%) as calculated using data recorded in participant recruitment log.

  Baseline to study completion

• Level of engagement

  Measured via semi-structured interviews or focus groups.

  12 weeks

• Adherence

  More than 80% rate of completion of at least five audio or video calls over 12 weeks and 100% rate of completion of all online outcome measures as calculated using data recorded in participant program tracking log.

  12 weeks

• Acceptability

  When the innovation is agreeable, palatable or satisfactory. Measured via focus groups or semi-structued interviews.

  12 weeks

• Barriers and enablers

  Measured via semi-structued interviews or focus groups.

  12 weeks

Secondary Outcomes (8)

• Perceived social role satisfaction (Mentors)

  Baseline to study completion, an average of 1 year

• Emotional distress (Mentors)

  Baseline to study completion, an average of 1 year

• Hope (Mentors)

  Baseline to study completion, an average of 1 year

• Disease self-management (Mentees)

  Baseline to 12 weeks post-program completion and 24 weeks post-program completion

• Percevied social support (Mentees)

  Baseline to 12 weeks post-program completion and 24 weeks post-program completion

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Behavioral: Peer Mentorship

Waitlist control

NO INTERVENTION

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.

Interventions

Peer Mentorship 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.

Also known as: Peer mentoring, Peer support

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Samantha Anthony: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Heart Failure; Chronic Disease; Cardiomyopathies; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samantha Anthony

CONTACT

416-813-7654; samantha.anthony@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomization process will be blinded to the principal investigator and co-investigators to reduce the chance of experimenter bias. Mentees and mentors will be asked not to discuss their study involvement with others outside of the study team until study completion.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Health Clinician Scientist

Model Details: A mixed methods pilot feasibility waitlist randomized controlled trial (RCT) design using central randomization with repeated measures, and following CONSORT guidelines, will be used to evaluate the iP2P program in young adult patients with heart disease. For clinical interventions, feasibility studies serve to identify potential refinements to the intervention, address uncertainties around the feasibility of intervention trial methods or test preliminary effects of the intervention. 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.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)