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OpenTrials
Completed

NCT Number: NCT04253548

iPeer2Peer Pediatric Thoracic Transplantation

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.

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Key information

Conditions

Solid Organ Transplant

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPeer2Peer Support Mentorship Program

Behavioral

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.

Primary outcomes

  1. Acceptability: Semi-structured Interview (Mentees)

    Time frame: 15 weeks after baseline/immediately after the intervention

    Semi-structured Interview

  2. Acceptability: Semi-structured Interview (Mentors)

    Time frame: Study completion, an average of 1 year

    Semi-structured Interview

  3. Adoption (Mentees)

    Time frame: 15 weeks after baseline/immediately after the intervention

    Semi-structured Interview

  4. Adoption (Mentors)

    Time frame: Study completion, an average of 1 year

    Semi-structured Interview

  5. Adoption

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

    Accrual and dropout rates

  6. Adoption

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

    Compliance with iPeer2Peer program

  7. Feasibility: Semi-structured Interview (Mentees)

    Time frame: 15 weeks after baseline/immediately after the intervention

    Semi-structured Interview

  8. Feasibility: Semi-structured Interview (Mentors)

    Time frame: Study completion, an average of 1 year

    Semi-structured Interview

  9. Feasibility: Accrual and dropout rates

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

    Accrual and dropout rates

  10. Feasibility: Compliance with iPeer2Peer program (Mentees)

    Time frame: 12 weeks post-program completion

    Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)

  11. Feasibility: Compliance with iPeer2Peer program (Mentors)

    Time frame: Study completion, an average of 1 year

    Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)

  12. Appropriateness (Mentees)

    Time frame: 15 weeks after baseline/immediately after the intervention

    Semi-structured Interview

  13. Appropriateness (Mentors)

    Time frame: Study completion, an average of 1 year

    Semi-structured Interview

  14. Level of Engagement (Mentees)

    Time frame: 15 weeks after baseline/immediately after the intervention

    Semi-structured Interview

  15. Level of Engagement (Mentors)

    Time frame: Study completion, an average of 1 year

    Semi-structured Interview

Secondary outcomes

  1. Disease self-management skills (Mentees)

    Time frame: 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.

  2. Treatment adherence (Mentees)

    Time frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

    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.

  3. Treatment adherence (Mentees)

    Time frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

    Immunosuppressant Blood Levels

  4. Treatment adherence (Mentees)

    Time frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion

    Clinic Attendance

  5. Quality of Life (Mentees)

    Time frame: 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.

  6. Perceived Social Support (Mentees)

    Time frame: 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.

  7. Emotional Distress (Mentees)

    Time frame: 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.

  8. Resiliency (Mentees)

    Time frame: 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.

  9. Quality of Mentor Behaviour (Mentees)

    Time frame: 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.

  10. Change in Physical and Emotional Symptoms (Mentors)

    Time frame: 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.

  11. Change in Perceived Social Role Satisfaction (Mentors)

    Time frame: 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.

  12. Change in Self-efficacy (Mentors): Chronic Disease Self-Efficacy Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Enduring Hearts
  • University of Alberta/Stollery Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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