iPeer2Peer Pediatric Thoracic Transplantation
- Conditions
- Solid Organ Transplant
- Interventions
- Behavioral: iPeer2Peer Support Mentorship Program
- Registration Number
- NCT04253548
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iPeer2Peer Program iPeer2Peer Support Mentorship Program Participates in the iPeer2Peer Program
- Primary Outcome Measures
Name Time Method Feasibility: Semi-structured Interview (Mentees) 15 weeks after baseline/immediately after the intervention Semi-structured Interview
Acceptability: Semi-structured Interview (Mentors) Study completion, an average of 1 year Semi-structured Interview
Level of Engagement (Mentors) Study completion, an average of 1 year Semi-structured Interview
Acceptability: Semi-structured Interview (Mentees) 15 weeks after baseline/immediately after the intervention Semi-structured Interview
Adoption (Mentees) 15 weeks after baseline/immediately after the intervention Semi-structured Interview
Adoption (Mentors) Study completion, an average of 1 year Semi-structured Interview
Adoption Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year Compliance with iPeer2Peer program
Feasibility: Semi-structured Interview (Mentors) Study completion, an average of 1 year Semi-structured Interview
Appropriateness (Mentors) Study completion, an average of 1 year Semi-structured Interview
Feasibility: Accrual and dropout rates Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year Accrual and dropout rates
Feasibility: Compliance with iPeer2Peer program (Mentees) 12 weeks post-program completion Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)
Feasibility: Compliance with iPeer2Peer program (Mentors) Study completion, an average of 1 year Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)
Appropriateness (Mentees) 15 weeks after baseline/immediately after the intervention Semi-structured Interview
Level of Engagement (Mentees) 15 weeks after baseline/immediately after the intervention Semi-structured Interview
- Secondary Outcome Measures
Name Time Method Treatment adherence (Mentees) Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion Clinic Attendance
Quality of Life (Mentees) Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion 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.
Resiliency (Mentees) Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion 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.
Quality of Mentor Behaviour (Mentees) 15 weeks after baseline/immediately after the intervention 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.
Disease self-management skills (Mentees) Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion Self-management skills assessment guide (questionnaire); 21-item questionnaire. Each question is scored on a scale from 1 to 5.
Perceived Social Support (Mentees) Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion 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.
Change in Physical and Emotional Symptoms (Mentors) Baseline, pre-intervention; study completion, an average of 1 year 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.
Change in Self-efficacy (Mentors): Chronic Disease Self-Efficacy Scale Baseline, pre-intervention; study completion, an average of 1 year 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.
Emotional Distress (Mentees) Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion 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.
Change in Perceived Social Role Satisfaction (Mentors) Baseline, pre-intervention; study completion, an average of 1 year 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.
Trial Locations
- Locations (1)
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada