iPeer2Peer Pediatric Thoracic Transplantation

Solid Organ Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253548
• Other study ID #: 1000065141
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Solid Organ Transplant

Intervention

Behavioral:
• iPeer2Peer Support Mentorship Program
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.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Enduring Hearts, University of Alberta/Stollery Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability: Semi-structured Interview (Mentees)	Semi-structured Interview	15 weeks after baseline/immediately after the intervention
Primary	Acceptability: Semi-structured Interview (Mentors)	Semi-structured Interview	Study completion, an average of 1 year
Primary	Adoption (Mentees)	Semi-structured Interview	15 weeks after baseline/immediately after the intervention
Primary	Adoption (Mentors)	Semi-structured Interview	Study completion, an average of 1 year
Primary	Adoption	Accrual and dropout rates	Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Primary	Adoption	Compliance with iPeer2Peer program	Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Primary	Feasibility: Semi-structured Interview (Mentees)	Semi-structured Interview	15 weeks after baseline/immediately after the intervention
Primary	Feasibility: Semi-structured Interview (Mentors)	Semi-structured Interview	Study completion, an average of 1 year
Primary	Feasibility: Accrual and dropout rates	Accrual and dropout rates	Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Primary	Feasibility: Compliance with iPeer2Peer program (Mentees)	Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)	12 weeks post-program completion
Primary	Feasibility: Compliance with iPeer2Peer program (Mentors)	Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)	Study completion, an average of 1 year
Primary	Appropriateness (Mentees)	Semi-structured Interview	15 weeks after baseline/immediately after the intervention
Primary	Appropriateness (Mentors)	Semi-structured Interview	Study completion, an average of 1 year
Primary	Level of Engagement (Mentees)	Semi-structured Interview	15 weeks after baseline/immediately after the intervention
Primary	Level of Engagement (Mentors)	Semi-structured Interview	Study completion, an average of 1 year
Secondary	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.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	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.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	Treatment adherence (Mentees)	Immunosuppressant Blood Levels	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	Treatment adherence (Mentees)	Clinic Attendance	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	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.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	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.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	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.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	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.	Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Secondary	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.	15 weeks after baseline/immediately after the intervention
Secondary	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.	Baseline, pre-intervention; study completion, an average of 1 year
Secondary	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.	Baseline, pre-intervention; study completion, an average of 1 year
Secondary	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.	Baseline, pre-intervention; study completion, an average of 1 year