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iPeer2Peer Pediatric Thoracic Transplantation

NCT ID: NCT04253548

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Organ Transplant

Keywords

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Peer Support Mentorship Transplant Pediatrics Adherence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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iPeer2Peer Program

Participates in the iPeer2Peer Program

Group Type EXPERIMENTAL

iPeer2Peer Support Mentorship Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. have a significant cognitive impairments as assessed by a qualified healthcare provider,
2. 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
3. are participating in other peer support or self-management interventions
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enduring Hearts

UNKNOWN

Sponsor Role collaborator

University of Alberta/Stollery Children's Hospital

UNKNOWN

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Samantha Anthony

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samantha J Anthony, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000065141

Identifier Type: -

Identifier Source: org_study_id