iPeer2Peer Pediatric Thoracic Transplantation

Study Overview
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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.

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

Conditions
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Solid Organ Transplant

Intervention / Treatment
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* Behavioral: iPeer2Peer Support Mentorship Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPeer2Peer Program<br>Participates in the iPeer2Peer Program | Behavioral: iPeer2Peer Support Mentorship Program<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer Support Mentorship, Transplant, Pediatrics, Adherence