Peers for Promoting Adolescent Transplant Health

Study Overview
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Brief Summary
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Adolescents with solid organ transplants have poorer outcomes than adults, and do not respond as well to post-rejection treatment. In addition to well-recognized declines in individual health-related quality of life, premature graft loss creates considerable health and economic burdens. High nonadherence rates among adolescents are believed to contribute majorly to rejection, premature allograft dysfunction and failure. Studies suggest that a telephone-based peer mentoring approach, with texting and e-communication, is a promising, practical means to promote medication adherence in adolescent solid organ transplant recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring to improve medication adherence and health-related quality of life vs. usual care in adolescents and young adults with solid organ transplants, and 2) to determine the mechanisms through which peer mentoring impacts medication adherence and health-related quality of life.

Detailed Description
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The investigators will conduct a single-center Phase II randomized clinical trial in which adolescents ages 14-23 and greater 3 months post solid organ transplant will receive either a peer mentor or usual care. The investigators will assess changes in quality of life from baseline to one year post-study entry. The investigators will also examine adherence changes over the same time frame using pharmacy refill data and a questionnaire. Peer mentors will provide social support and promote subject self-efficacy primarily via e-communication. Changes in social support and self-efficacy will be measured over a one-year period.

Official Title
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A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants

Conditions
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Behavior and Behavior Mechanisms

Intervention / Treatment
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* Behavioral: Peer Mentoring
* Behavioral: e-Communication with mentor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 14 to 23 years Greater than one year post kidney, heart or liver transplant Able to speak and read in English Willing and able to provide informed consent or assent Parental guardian permission (informed consent) if appropriate Exclusion Criteria: Unwilling to participate Unable to speak or read in English Unable to provide informed assent or consent Estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m^2 On dialysis Less than three months post transplant Post-transplant lymphoproliferative disease

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Standard of care | |
| Experimental: Mentoring group<br>Subjects in this group will participate in the following intervention activities: medical record review; questionnaires including the Hollingshead Socioeconomic Status Survey, modified Medication Adherence Module, Peds QL Transplant Module, Medical Outcomes Study Social Support Scale, and self-efficacy scale; in-person meetings with mentor; e-communication with mentor (i.e. texts, Facebook, phone calls, etc); and collection of pharmacy refill data and clinical data. | Behavioral: Peer Mentoring<br>* Subjects will be assigned a peer mentor who will provide social support primarily via e-communication. They will also meet in-person at study entry, 6 months and 1-year.<br>Behavioral: e-Communication with mentor<br>* Subjects will interact on a mutually agreeable basis via their choice of text messaging, Facebook, phone calls, emails, and other formats<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | The primary endpoint is medication adherence, defined by the modified Medication Adherence Module (MAM), standard deviations of immunosuppressive drug levels, percent adherence from pharmacy refill data and pill counts at 1 year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mentoring mechanisms | The secondary endpoint is to determine the mechanisms through which peer mentoring impacts medication adherence and healthcare-related quality of life. It is hypothesized that peer mentors will provide social support which will improve subject self-efficacy. | 1 year | 
| Quality of Life | Health-related Quality of Life (QL) will be measured using the Peds QL Transplant Module. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney, mentor, medication, renal, transplant, transplantation, adolescent, pediatric, mentoring, adherence, immunosuppressant, heart, liver