Solid Organ TransplantNCT04253548
iPeer2Peer Pediatric Thoracic Transplantation
A study testing iPeer2Peer Support Mentorship Program in people with Solid Organ Transplant, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Solid Organ Transplant
- What is being tested?
- iPeer2Peer Support Mentorship Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Solid Organ Transplant
- Being tested
- iPeer2Peer Support Mentorship Program
- Keywords
- Peer Support Mentorship, Transplant, Pediatrics, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPeer2Peer Support Mentorship ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iPeer2Peer Program | Experimental | Participates in the iPeer2Peer Program Receives: Behavioral: iPeer2Peer Support Mentorship Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability: Semi-structured Interview (Mentees)
Semi-structured Interview
Measured: 15 weeks after baseline/immediately after the intervention
Acceptability: Semi-structured Interview (Mentors)
Semi-structured Interview
Measured: Study completion, an average of 1 year
Adoption (Mentees)
Semi-structured Interview
Measured: 15 weeks after baseline/immediately after the intervention
Adoption (Mentors)
Semi-structured Interview
Measured: Study completion, an average of 1 year
Adoption
Accrual and dropout rates
Measured: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Adoption
Compliance with iPeer2Peer program
Measured: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Feasibility: Semi-structured Interview (Mentees)
Semi-structured Interview
Measured: 15 weeks after baseline/immediately after the intervention
Feasibility: Semi-structured Interview (Mentors)
Semi-structured Interview
Measured: Study completion, an average of 1 year
Feasibility: Accrual and dropout rates
Accrual and dropout rates
Measured: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Feasibility: Compliance with iPeer2Peer program (Mentees)
Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)
Measured: 12 weeks post-program completion
Feasibility: Compliance with iPeer2Peer program (Mentors)
Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)
Measured: Study completion, an average of 1 year
Appropriateness (Mentees)
Semi-structured Interview
Measured: 15 weeks after baseline/immediately after the intervention
Appropriateness (Mentors)
Semi-structured Interview
Measured: Study completion, an average of 1 year
Level of Engagement (Mentees)
Semi-structured Interview
Measured: 15 weeks after baseline/immediately after the intervention
Level of Engagement (Mentors)
Semi-structured Interview
Measured: Study completion, an average of 1 year
Secondary outcomes (12)
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.
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)
Immunosuppressant Blood Levels
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
Treatment adherence (Mentees)
Clinic Attendance
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Measured: Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion
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.
Measured: 15 weeks after baseline/immediately after the intervention
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.
Measured: Baseline, pre-intervention; study completion, an average of 1 year
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.
Measured: Baseline, pre-intervention; study completion, an average of 1 year
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.
Measured: Baseline, pre-intervention; study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 May 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Enduring Hearts, University of Alberta/Stollery Children's Hospital
- Responsible party
- Principal investigator, Samantha Anthony, The Hospital for Sick Children
- Investigators
- Samantha J Anthony, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253548
- Sponsor's protocol ID
- 1000065141
- Status last verified
- Dec 2023
- First submitted
- 22 Jan 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program Within Pediatric Thoracic Transplantation
- ClinicalTrials.gov ID
- NCT04253548
- Acronym / sponsor ID
- 1000065141
- Conditions
- Solid Organ Transplant
- Keywords
- Peer Support Mentorship, Transplant, Pediatrics, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Enduring Hearts, University of Alberta/Stollery Children's Hospital
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iPeer2Peer Program | Experimental | Behavioral: iPeer2Peer Support Mentorship ProgramParticipates in the iPeer2Peer Program |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPeer2Peer Support Mentorship ProgramiPeer2Peer 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. | Behavioural | iPeer2Peer Program |
Primary outcome
Acceptability: Semi-structured Interview (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Acceptability: Semi-structured Interview (Mentors)
Time frame: Study completion, an average of 1 year
Semi-structured Interview
Adoption (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Adoption (Mentors)
Time frame: Study completion, an average of 1 year
Semi-structured Interview
Adoption
Time frame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Accrual and dropout rates
Adoption
Time frame: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Compliance with iPeer2Peer program
Feasibility: Semi-structured Interview (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Feasibility: Semi-structured Interview (Mentors)
Time frame: Study completion, an average of 1 year
Semi-structured Interview
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
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)
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)
Appropriateness (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Appropriateness (Mentors)
Time frame: Study completion, an average of 1 year
Semi-structured Interview
Level of Engagement (Mentees)
Time frame: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Level of Engagement (Mentors)
Time frame: Study completion, an average of 1 year
Semi-structured Interview
12 secondary outcomes
Disease self-management skills (Mentees)
Time frame: 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
Treatment adherence (Mentees)
Time frame: 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
Quality of Life (Mentees)
Time frame: 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
Emotional Distress (Mentees)
Time frame: 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
Quality of Mentor Behaviour (Mentees)
Time frame: 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
Change in Perceived Social Role Satisfaction (Mentors)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha J Anthony, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPeer2Peer Support Mentorship Program in people with Solid Organ Transplant, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: Semi-structured Interview (Mentees) (time frame: 15 weeks after baseline/immediately after the intervention). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.