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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Peer Mentorship
BehavioralThe 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
Trial outcomes
Primary outcomes
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.
Level of engagement
Measured via semi-structured interviews or focus groups.
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.
Acceptability
When the innovation is agreeable, palatable or satisfactory. Measured via focus groups or semi-structued interviews.
Secondary outcomes
Perceived social role satisfaction (Mentors)
Measured by the PROMIS Satisfaction with Social Roles and Activities
Emotional distress (Mentors)
Measured by the General Anxiety Disorder-7 and the Patient Health Questionnaire Depression Scale
Hope (Mentors)
Measured by the Adult Hope Scale
Disease self-management (Mentees)
Measured by the Partners in Health Scale
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: