Clinical trial NCT01450033: Peers for Promoting Adolescent Transplant Health
Official title: A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: kidney
renal
transplant
transplantation
adolescent
pediatric
mentor
mentoring
medication
adherence
immunosuppressant
heart
liver
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-10-12
Enrollment: 74
Sex: ALL
Minimum age (years): 14
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence
timeFrame: 1 year
Secondary outcomes:
measure: Mentoring mechanisms
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sandra Amaral, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.