Peers for Promoting Adolescent Transplant Health (Peers4PATH)
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.
Behavior and Behavior Mechanisms
Behavioral: Peer Mentoring
Behavioral: e-Communication with mentor
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants|
- Medication adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Mentoring mechanisms [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]Health-related Quality of Life will be measured using the Peds QL Transplant Module.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
No Intervention: Control group
Standard of care
Experimental: Mentoring group
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
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.Behavioral: e-Communication with mentor
Subjects will interact on a mutually agreeable basis via their choice of text messaging, Facebook, phone calls, emails, and other formats
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450033
|Contact: Sandra Amaral, MD, MHSemail@example.com|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Sandra Amaral, MD, MHS 267-426-1452 firstname.lastname@example.org|
|Principal Investigator: Sandra Amaral, MD, MHS|
|Principal Investigator:||Sandra Amaral, MD, MHS||Children's Hospital of Philadelphia|