Peers for Promoting Adolescent Transplant Health

Not Applicable

Completed

• Conditions: Behavior and Behavior Mechanisms
• Interventions: Behavioral: Peer Mentoring; Behavioral: e-Communication with mentor

• Registration Number: NCT01450033
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-12
• Primary Completion: 2017-01
• Study Completion: 2017-03-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mentoring group	e-Communication with mentor	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.
Mentoring group	Peer Mentoring	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.

Primary Outcome Measures

Name	Time	Method
Medication adherence	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Mentoring mechanisms	1 year	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.
Quality of Life	1 year	Health-related Quality of Life (QL) will be measured using the Peds QL Transplant Module.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States