NCT04253548

Brief Summary

With the on-going presence of a chronic illness, daily immunosuppressive medications, and the need for continuous medical supervision, pediatric transplant recipients face considerable psychosocial stresses. Treatment nonadherence is a major issue in pediatric transplantation and can lead to increased rates of hospitalization, rejection episodes, graft loss and death. An online peer support mentorship program (iPeer2Peer) is proposed as one intervention that could enhance patient care management, increase treatment adherence, reduce social isolation and improve health outcomes for this highly vulnerable population. The proposed trial will determine 1) implementation outcomes of the iPeer2Peer intervention in terms of: (a) feasibility and adoption, (b) acceptability and appropriateness and (c) level of engagement with the program, and 2) effectiveness of the iPeer2Peer intervention on improving health outcomes including disease self-management skills, treatment adherence, quality of life, perceived social support, stress and coping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

January 22, 2020

Last Update Submit

December 15, 2023

Conditions

Solid Organ Transplant

Keywords

Peer Support MentorshipTransplantPediatricsAdherence

Outcome Measures

Primary Outcomes (15)

  • Acceptability: Semi-structured Interview (Mentees)

    Semi-structured Interview

    15 weeks after baseline/immediately after the intervention

  • Acceptability: Semi-structured Interview (Mentors)

    Semi-structured Interview

    Study completion, an average of 1 year

  • Adoption (Mentees)

    Semi-structured Interview

    15 weeks after baseline/immediately after the intervention

  • Adoption (Mentors)

    Semi-structured Interview

    Study completion, an average of 1 year

  • Adoption

    Accrual and dropout rates

    Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

  • Adoption

    Compliance with iPeer2Peer program

    Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

  • Feasibility: Semi-structured Interview (Mentees)

    Semi-structured Interview

    15 weeks after baseline/immediately after the intervention

  • Feasibility: Semi-structured Interview (Mentors)

    Semi-structured Interview

    Study completion, an average of 1 year

  • Feasibility: Accrual and dropout rates

    Accrual and dropout rates

    Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

  • Feasibility: Compliance with iPeer2Peer program (Mentees)

    Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)

    12 weeks post-program completion

  • Feasibility: Compliance with iPeer2Peer program (Mentors)

    Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)

    Study completion, an average of 1 year

  • Appropriateness (Mentees)

    Semi-structured Interview

    15 weeks after baseline/immediately after the intervention

  • Appropriateness (Mentors)

    Semi-structured Interview

    Study completion, an average of 1 year

  • Level of Engagement (Mentees)

    Semi-structured Interview

    15 weeks after baseline/immediately after the intervention

  • Level of Engagement (Mentors)

    Semi-structured Interview

    Study completion, an average of 1 year

Secondary Outcomes (12)

  • Disease self-management skills (Mentees)

    Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

  • Treatment adherence (Mentees)

    Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

  • Treatment adherence (Mentees)

    Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

  • Treatment adherence (Mentees)

    Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

  • Quality of Life (Mentees)

    Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

  • +7 more secondary outcomes

Study Arms (1)

iPeer2Peer Program

EXPERIMENTAL

Participates in the iPeer2Peer Program

Behavioral: iPeer2Peer Support Mentorship Program

Interventions

iPeer2Peer Support Mentorship ProgramBEHAVIORAL

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.

iPeer2Peer Program

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • heart and/or lung transplant recipient,
  • at least 4 months post-transplant,
  • between the ages of 12 and 25 years,
  • able to speak and read English,
  • willingness to commit to 5-10 texts and/or calls of 20-30 minutes each over a period of 15 weeks.

You may not qualify if:

  • have a significant cognitive impairments as assessed by a qualified healthcare provider,
  • have 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 transplant regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
  • are participating in other peer support or self-management interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

  • Samantha J Anthony, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2020

First Posted

February 5, 2020

Study Start

May 20, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)