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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
34
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.
Hospital for Sick Children
Toronto, Ontario, Canada
Acceptability: Semi-structured Interview (Mentees)
Semi-structured Interview
Time frame: 15 weeks after baseline/immediately after the intervention
Acceptability: Semi-structured Interview (Mentors)
Semi-structured Interview
Time frame: Study completion, an average of 1 year
Adoption (Mentees)
Semi-structured Interview
Time frame: 15 weeks after baseline/immediately after the intervention
Adoption (Mentors)
Semi-structured Interview
Time frame: Study completion, an average of 1 year
Adoption
Accrual and dropout rates
Time frame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Adoption
Compliance with iPeer2Peer program
Time frame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Feasibility: Semi-structured Interview (Mentees)
Semi-structured Interview
Time frame: 15 weeks after baseline/immediately after the intervention
Feasibility: Semi-structured Interview (Mentors)
Semi-structured Interview
Time frame: Study completion, an average of 1 year
Feasibility: Accrual and dropout rates
Accrual and dropout rates
Time frame: 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)
Time frame: 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)
Time frame: Study completion, an average of 1 year
Appropriateness (Mentees)
Semi-structured Interview
Time frame: 15 weeks after baseline/immediately after the intervention
Appropriateness (Mentors)
Semi-structured Interview
Time frame: Study completion, an average of 1 year
Level of Engagement (Mentees)
Semi-structured Interview
Time frame: 15 weeks after baseline/immediately after the intervention
Level of Engagement (Mentors)
Semi-structured Interview
Time frame: Study completion, an average of 1 year
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.
Time frame: 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.
Time frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)
Immunosuppressant Blood Levels
Time frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)
Clinic Attendance
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, pre-intervention; study completion, an average of 1 year