Peers for Promoting Adolescent Transplant Health (Peers4PATH)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Behavior and Behavior Mechanisms

Treatments: Behavioral: Peer Mentoring; Behavioral: e-Communication with mentor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01450033

11-008336

DK083529 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 14 to 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Control group

No Intervention group

Description:

Standard of care

Mentoring group

Experimental group

Description:

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.

Treatment:

Behavioral: Peer Mentoring

Behavioral: e-Communication with mentor