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Recruiting NCT05709132

iP2P Mentorship Program for Adolescent HF Patients

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iPeer2Peer Program.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: 12 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Function Patients

Overview

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 quasi-experimental single-arm pre-post study design will be employed across three sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-30 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.

Interventions

  • Behavioral iPeer2Peer Program
    Behavioral: iPeer2Peer Support Mentorship Program is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees.

Primary outcome measures

  • Acceptability (Mentees) [Time frame: 15 weeks after baseline/immediately after the intervention]
  • Acceptability (Mentors) [Time frame: Study completion, an average of 1 year]
  • Adoption (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Adoption (Mentors) [Time frame: Baseline to study completion, an average of 1 year]
  • Feasibility (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Feasibility (Mentors) [Time frame: Baseline to study completion, an average of 1 year]
  • Appropriateness (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Appropriateness (Mentors) [Time frame: Baseline to study completion, an average of 1 year]
  • Level of engagement (Mentees) [Time frame: 15 weeks after baseline/immediately after the intervention]
  • Level of engagement (Mentors) [Time frame: Study completion, an average of 1 year]
Secondary outcome measures (10)
  • Disease self-management skills (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Adherence (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Quality of life (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Perceived social support (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Emotional distress (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Resiliency (Mentees) [Time frame: Baseline to 12 weeks post-program completion]
  • Assessment of mentor quality (Mentees) [Time frame: 15 weeks after baseline/immediately after the intervention]
  • Physical and emotional symptoms (Mentors) [Time frame: Baseline to study completion, an average of 1 year]
  • Perceived social role satisfaction (Mentors) [Time frame: Baseline to study completion, an average of 1 year]
  • Self-efficacy (Mentors) [Time frame: Baseline to study completion, an average of 1 year]

Eligibility criteria

Mentee inclusion criteria:

  • patient with a cardiac diagnosis,
  • at least 4 months post-diagnosis,
  • between the ages of 12 and 17 years,
  • able to speak and read English, and
  • 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:

  • patient with a cardiac diagnosis,
  • between the ages of 18 and 30 years,
  • able to speak and read English,
  • nominated by a member of their health care team as a good mentor based on maturity and emotional stability,
  • 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),
  • good communication skills (as assessed by a healthcare provider), and
  • previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset.

Exclusion criteria

  • significant cognitive impairments as assessed by a qualified healthcare provider,
  • 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
  • participating in other peer support or self-management interventions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT05709132 · 1000080204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗