Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

iPeer2Peer Pediatric Thoracic Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253548
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Enduring Hearts
University of Alberta/Stollery Children's Hospital
Information provided by (Responsible Party):
Samantha Anthony, The Hospital for Sick Children

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Organ Transplant Behavioral: iPeer2Peer Support Mentorship Program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Implementation and Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program Within Pediatric Thoracic Transplantation
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: 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.

Standard of Care
Waitlist Control Group
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253548


Contacts
Layout table for location contacts
Contact: Sarah Pol 416-813-7654 ext 308084 sarah.pol@sickkids.ca

Sponsors and Collaborators
The Hospital for Sick Children
Enduring Hearts
University of Alberta/Stollery Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Samantha J Anthony, PhD The Hospital for Sick Children
Layout table for additonal information
Responsible Party: Samantha Anthony, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04253548    
Other Study ID Numbers: 1000065141
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samantha Anthony, The Hospital for Sick Children:
Peer Support Mentorship
Transplant
Pediatrics
Adherence