CompletedNot Applicable

iPeer2Peer Pediatric Thoracic Transplantation

Canada34 participantsStarted 2021-05-20

Plain-language 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.

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability: Semi-structured Interview (Mentees)

Timeframe: 15 weeks after baseline/immediately after the intervention

Acceptability: Semi-structured Interview (Mentors)

Timeframe: Study completion, an average of 1 year

Adoption (Mentees)

Timeframe: 15 weeks after baseline/immediately after the intervention

Adoption (Mentors)

Timeframe: Study completion, an average of 1 year

Adoption

Timeframe: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

Adoption

Timeframe: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

Feasibility: Semi-structured Interview (Mentees)

Timeframe: 15 weeks after baseline/immediately after the intervention

Trial details

NCT IDNCT04253548

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Solid Organ Transplant trials

Plain-language summary

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Acceptability: Semi-structured Interview (Mentees)

Timeframe: 15 weeks after baseline/immediately after the intervention

Acceptability: Semi-structured Interview (Mentors)

Timeframe: Study completion, an average of 1 year

Adoption (Mentees)

Timeframe: 15 weeks after baseline/immediately after the intervention

Adoption (Mentors)

Timeframe: Study completion, an average of 1 year

Adoption

Timeframe: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

Adoption

Timeframe: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year

Feasibility: Semi-structured Interview (Mentees)

Timeframe: 15 weeks after baseline/immediately after the intervention