Peers for Promoting Adolescent Transplant Health

Behavior and Behavior Mechanisms Clinical Trial

— Peers4PATH  

Official title:

A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450033
• Other study ID #: 11-008336
• Secondary ID: DK083529
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 29, 2017

Study information

• Verified date: May 2018
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 29, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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.	1 year
Secondary	Mentoring mechanisms	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.	1 year
Secondary	Quality of Life	Health-related Quality of Life (QL) will be measured using the Peds QL Transplant Module.	1 year