iP2P Mentorship Program for Teen HF Patients (iP2P HF)

January 24, 2024 updated by: Samantha Anthony, The Hospital for Sick Children

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Samantha J Anthony, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Mentee inclusion criteria:

  1. heart failure patient,
  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. heart failure patient,
  2. between the ages of 18 and 25 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iPeer2Peer Program
Behavioral: iPeer2Peer Program
Behavioral: iPeer2Peer Support Mentorship Program iPeer2Peer 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.
No Intervention: Standard of Care Waitlist Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
Whether the innovation is agreeable, palatable or satisfactory
15 weeks after baseline/immediately after the intervention
Acceptability (Mentors)
Time Frame: Study completion, an average of 1 year
Whether the innovation is agreeable, palatable or satisfactory
Study completion, an average of 1 year
Adoption (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
The intention, initial decision or action to try or use an innovation
Baseline to 12 weeks post-program completion
Adoption (Mentors)
Time Frame: Baseline to study completion, an average of 1 year
The intention, initial decision or action to try or use an innovation
Baseline to study completion, an average of 1 year
Feasibility (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
The extent to which an innovation can be used or carried out successfully in a given setting
Baseline to 12 weeks post-program completion
Feasibility (Mentors)
Time Frame: Baseline to study completion, an average of 1 year
The extent to which an innovation can be used or carried out successfully in a given setting
Baseline to study completion, an average of 1 year
Appropriateness (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Baseline to 12 weeks post-program completion
Appropriateness (Mentors)
Time Frame: Baseline to study completion, an average of 1 year
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Baseline to study completion, an average of 1 year
Level of engagement (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
15 weeks after baseline/immediately after the intervention
Level of engagement (Mentors)
Time Frame: Study completion, an average of 1 year
Study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease self-management skills (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
Baseline to 12 weeks post-program completion
Adherence (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale
Baseline to 12 weeks post-program completion
Quality of life (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
Baseline to 12 weeks post-program completion
Perceived social support (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
Baseline to 12 weeks post-program completion
Emotional distress (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
Baseline to 12 weeks post-program completion
Resiliency (Mentees)
Time Frame: Baseline to 12 weeks post-program completion
Baseline to 12 weeks post-program completion
Assessment of mentor quality (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
15 weeks after baseline/immediately after the intervention
Physical and emotional symptoms (Mentors)
Time Frame: Baseline to study completion, an average of 1 year
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
Baseline to study completion, an average of 1 year
Self-efficacy (Mentors)
Time Frame: Baseline to study completion, an average of 1 year
Baseline to study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

British Columbia Children's Hospital
University of Alberta/Stollery Children's Hospital
The Centre Hospitalier Universitaire Sainte-Justine

Investigators

  • Principal Investigator: Samantha J Anthony, PhD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

April 13, 2027

Study Completion (Estimated)

April 13, 2027

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000080204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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