iPeer2Peer Pediatric Thoracic Transplantation

Implementation and Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program Within Pediatric Thoracic Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Solid Organ Transplant
• Intervention / Treatment: Behavioral: iPeer2Peer Support Mentorship Program

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iPeer2Peer Program; Participates in the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease self-management skills (Mentees)	Self-management skills assessment guide (questionnaire); 21-item questionnaire. Each question is scored on a scale from 1 to 5.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)	Adolescent Medication Barriers Scale; 17-item questionnaire with 3 different sections: Disease Frustration/Adolescent Issues, Ingestion Issues, and Regimen Adaptation/Cognitive. Each question is scored on a scale from 1 to 5. An overall higher score means a worse outcome.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)	Immunosuppressant Blood Levels	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)	Clinic Attendance	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Quality of Life (Mentees)	Pediatric Quality of Life Inventory™ 3.0 Transplant Module; 46-item questionnaire with 8 different sections: About My Medicines I, About My Medicines II, My Transplant and Others, Pain and Hurt, Worry, Treatment Anxiety, How I Look, and Communication. Each question is scored on a scale from 0 to 4. An overall higher score means a better outcome.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Perceived Social Support (Mentees)	National Institute of Health Emotional Support Survey; 7-item questionnaire. Each question is scored on a scale from 1 to 5. An overall higher score means a better outcome.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Emotional Distress (Mentees)	Revised Child Anxiety and Depression Scale - short version; 25-item questionnaire. Each question is scored on a scale with 4 possible responses. An overall higher score means a worse outcome.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Resiliency (Mentees)	Brief Resilience Scale; 6-item questionnaire. Each question is scored on a scale with 5 possible responses. An overall higher score means a better outcome.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Quality of Mentor Behaviour (Mentees)	Mentor Behaviour Scale; 15-item questionnaire with 4 different sections: Structure, Engagement, Autonomy Support, and Competency Support. Each question is scored on a scale from 1 to 5.	15 weeks after baseline/immediately after the intervention
Change in Physical and Emotional Symptoms (Mentors)	PROMIS - 29 Adult Profile v2.1; Maximum 29-item questionnaire as responses to some questions may lead participants to answer fewer questions. There are 8 different sections: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. Each question is scored on a scale from 1 to 5.	Baseline, pre-intervention; study completion, an average of 1 year
Change in Perceived Social Role Satisfaction (Mentors)	PROMIS Satisfaction with Social Roles and Activities; Maximum 44-item questionnaire as responses to some questions may lead participants to answer fewer questions. Each question is scored on a scale from 1 to 5. An overall higher score means a better outcome.	Baseline, pre-intervention; study completion, an average of 1 year
Change in Self-efficacy (Mentors): Chronic Disease Self-Efficacy Scale	Chronic Disease Self-Efficacy Scale; 33-item questionnaire with 10 different sections: Exercise Regularly Scale, Get Information About Disease Item, Obtain Help from Community/Family/Friends Scale, Communicate With Physician Scale, Manage Disease in General Scale, Do Chores Scale, Social/Recreational Activities Scale, Manage Symptoms Scale, Manage Shortness of Breath Item, and Control/Manage Depression Scale. Each question is scored on a scale from 1 to 10. An overall higher score means a better outcome.	Baseline, pre-intervention; study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Enduring Hearts; University of Alberta/Stollery Children's Hospital
• Investigators: Principal Investigator: Samantha J Anthony, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Pediatrics; Transplant; Peer Support Mentorship
• Other Study ID Numbers: 1000065141

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