Clinical trial NCT05709132: iP2P Mentorship Program for Teen HF Patients
Official title: Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Function Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Peer Support Mentorship
Pediatrics
Adherence
Cardiomyopathy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Alberta/Stollery Children's Hospital
name: British Columbia Children's Hospital
name: The Centre Hospitalier Universitaire Sainte-Justine
First posted: 2023-02-01
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist randomized controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: Mentee inclusion criteria:

1. patient with a cardiac diagnosis,
2. at least 4 months post-diagnosis,
3. between the ages of 12 and 17 years,
4. able to speak and read English, and
5. willingness to commit to 5-10 texts and/or calls of 20-30 minutes each with a peer mentor over a period of 15 weeks.

Mentor inclusion criteria:

1. patient with a cardiac diagnosis,
2. between the ages of 18 and 30 years,
3. able to speak and read English,
4. nominated by a member of their health care team as a good mentor based on maturity and emotional stability,
5. willingness to commit to peer mentor training (20 hours) via the PHIPA-compliant version of Zoom or Microsoft Teams and mentoring adolescent participants (once paired with mentee, 5-10 texts and/or calls of 20-30 minutes over a period of 15 weeks),
6. good communication skills (as assessed by a healthcare provider), and
7. previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset.

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.

Primary outcomes:
measure: Acceptability (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Acceptability (Mentors)
timeFrame: Study completion, an average of 1 year
measure: Adoption (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Adoption (Mentors)
timeFrame: Baseline to study completion, an average of 1 year
measure: Feasibility (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Feasibility (Mentors)
timeFrame: Baseline to study completion, an average of 1 year
measure: Appropriateness (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Appropriateness (Mentors)
timeFrame: Baseline to study completion, an average of 1 year
measure: Level of engagement (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Level of engagement (Mentors)
timeFrame: Study completion, an average of 1 year
Secondary outcomes:
measure: Disease self-management skills (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Adherence (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Quality of life (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Perceived social support (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Emotional distress (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Resiliency (Mentees)
timeFrame: Baseline to 12 weeks post-program completion
measure: Assessment of mentor quality (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Physical and emotional symptoms (Mentors)
timeFrame: Baseline to study completion, an average of 1 year
measure: Perceived social role satisfaction (Mentors)
timeFrame: Baseline to study completion, an average of 1 year
measure: Self-efficacy (Mentors)
timeFrame: Baseline to study completion, an average of 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Samantha J Anthony, PhD
role: PRINCIPAL_INVESTIGATOR
References: