Clinical trial NCT04253548: iPeer2Peer Pediatric Thoracic Transplantation
Official title: Implementation and Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program Within Pediatric Thoracic Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Organ Transplant
Keywords: Peer Support Mentorship
Transplant
Pediatrics
Adherence
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Enduring Hearts
name: University of Alberta/Stollery Children's Hospital
First posted: 2020-02-05
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability: Semi-structured Interview (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Acceptability: Semi-structured Interview (Mentors)
timeFrame: Study completion, an average of 1 year
measure: Adoption (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Adoption (Mentors)
timeFrame: Study completion, an average of 1 year
measure: Adoption
timeFrame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
measure: Adoption
timeFrame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
measure: Feasibility: Semi-structured Interview (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Feasibility: Semi-structured Interview (Mentors)
timeFrame: Study completion, an average of 1 year
measure: Feasibility: Accrual and dropout rates
timeFrame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
measure: Feasibility: Compliance with iPeer2Peer program (Mentees)
timeFrame: 12 weeks post-program completion
measure: Feasibility: Compliance with iPeer2Peer program (Mentors)
timeFrame: Study completion, an average of 1 year
measure: Appropriateness (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Appropriateness (Mentors)
timeFrame: Study completion, an average of 1 year
measure: Level of Engagement (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Level of Engagement (Mentors)
timeFrame: Study completion, an average of 1 year
Secondary outcomes:
measure: Disease self-management skills (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Treatment adherence (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Treatment adherence (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Treatment adherence (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Quality of Life (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Perceived Social Support (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Emotional Distress (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Resiliency (Mentees)
timeFrame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
measure: Quality of Mentor Behaviour (Mentees)
timeFrame: 15 weeks after baseline/immediately after the intervention
measure: Change in Physical and Emotional Symptoms (Mentors)
timeFrame: Baseline, pre-intervention; study completion, an average of 1 year
measure: Change in Perceived Social Role Satisfaction (Mentors)
timeFrame: Baseline, pre-intervention; study completion, an average of 1 year
measure: Change in Self-efficacy (Mentors): Chronic Disease Self-Efficacy Scale
timeFrame: Baseline, pre-intervention; study completion, an average of 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Samantha J Anthony, PhD
role: PRINCIPAL_INVESTIGATOR
References: