The iPeer2Peer Mentorship Program for Young Adults With Heart Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorSamantha Anthony

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Peer Mentor inclusion criteria: (a) heart disease patients, (b) at least three months post-diagnosis, (c) between the ages of 26-35 years old, (d) nominated by a member of their healthcare team as a good candidate to act in the mentor role based on maturity and emotional stability (e.g., good communication skills, positive adaptation and adjustment, strong support network), (e) willingness to commit to virtual peer mentor training, (f) able to speak and read English, and (g) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.

Peer Mentee inclusion criteria: (a) heart disease patients, (b) between the ages of 18-25 years old, (c) able to speak and read English, and (d) access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software.

Patients with any past or present heart failure

Patients with cardiomyopathy seen at least 2 times a year

Disqualifiers

Mentor and mentee exclusion criteria include: (a) Significant cognitive impairments as assessed by a qualified healthcare provider (HCP), (b) have a diagnosis of an active psychological disorder (e.g.: Major Depressive Disorder, etc.; determined through chart review by a qualified HCP) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart disease care regimen, and (c) are participating in other peer support or self-management interventions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to study completion
2

Level of engagement

Measured via semi-structured interviews or focus groups.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

Acceptability

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

Time frame
12 weeks

Secondary outcomes

1

Perceived social role satisfaction (Mentors)

Measured by the PROMIS Satisfaction with Social Roles and Activities

Time frame
Baseline to study completion, an average of 1 year
2

Emotional distress (Mentors)

Measured by the General Anxiety Disorder-7 and the Patient Health Questionnaire Depression Scale

Time frame
Baseline to study completion, an average of 1 year
3

Hope (Mentors)

Measured by the Adult Hope Scale

Time frame
Baseline to study completion, an average of 1 year
4

Disease self-management (Mentees)

Measured by the Partners in Health Scale

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samantha Anthony

Lead sponsor

The Hospital for Sick Children

Sponsor institution

Heart and Stroke Foundation of Canada

Collaborator

This trial is not recruiting at the moment. You can still explore other options: