This trial is active, not recruiting.

Condition behavior and behavior mechanisms
Treatments peer mentoring, e-communication with mentor
Phase phase 2
Sponsor Children's Hospital of Philadelphia
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date September 2011
End date November 2016
Trial size 74 participants
Trial identifier NCT01450033, 11-008336, DK083529


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(No Intervention)
Standard of care
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.
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.
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

Primary Outcomes

Medication adherence
time frame: 1 year

Secondary Outcomes

Mentoring mechanisms
time frame: 1 year
Quality of Life
time frame: 1 year

Eligibility Criteria

Male or female participants from 14 years up to 23 years old.

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

Additional Information

Official title A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants
Principal investigator Sandra Amaral, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.