iPeer2Peer Pediatric Thoracic Transplantation

December 15, 2023 updated by: Samantha Anthony, The Hospital for Sick Children

Implementation and Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program Within 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: iPeer2Peer Program
Participates in the iPeer2Peer Program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability: Semi-structured Interview (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
15 weeks after baseline/immediately after the intervention
Acceptability: Semi-structured Interview (Mentors)
Time Frame: Study completion, an average of 1 year
Semi-structured Interview
Study completion, an average of 1 year
Adoption (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
15 weeks after baseline/immediately after the intervention
Adoption (Mentors)
Time Frame: Study completion, an average of 1 year
Semi-structured Interview
Study completion, an average of 1 year
Adoption
Time Frame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Accrual and dropout rates
Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Adoption
Time Frame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Compliance with iPeer2Peer program
Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Feasibility: Semi-structured Interview (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
15 weeks after baseline/immediately after the intervention
Feasibility: Semi-structured Interview (Mentors)
Time Frame: Study completion, an average of 1 year
Semi-structured Interview
Study completion, an average of 1 year
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
Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
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)
12 weeks post-program completion
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)
Study completion, an average of 1 year
Appropriateness (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
15 weeks after baseline/immediately after the intervention
Appropriateness (Mentors)
Time Frame: Study completion, an average of 1 year
Semi-structured Interview
Study completion, an average of 1 year
Level of Engagement (Mentees)
Time Frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
15 weeks after baseline/immediately after the intervention
Level of Engagement (Mentors)
Time Frame: Study completion, an average of 1 year
Semi-structured Interview
Study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)
Time Frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Immunosuppressant Blood Levels
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)
Time Frame: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Clinic Attendance
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
15 weeks after baseline/immediately after the intervention
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.
Baseline, pre-intervention; study completion, an average of 1 year
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.
Baseline, pre-intervention; study completion, an average of 1 year
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.
Baseline, pre-intervention; study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Enduring Hearts
University of Alberta/Stollery Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samantha J Anthony, PhD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000065141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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