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OpenTrials
Completed

NCT Number: NCT01450033

Peers for Promoting Adolescent Transplant Health

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.

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Key information

Conditions

Behavior and Behavior Mechanisms Behavior

Age range

14 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Mentoring

Behavioral

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

Behavioral

Subjects will interact on a mutually agreeable basis via their choice of text messaging, Facebook, phone calls, emails, and other formats

Primary outcomes

  1. Medication adherence

    Time frame: 1 year

    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.

Secondary outcomes

  1. Mentoring mechanisms

    Time frame: 1 year

    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.

  2. Quality of Life

    Time frame: 1 year

    Health-related Quality of Life (QL) will be measured using the Peds QL Transplant Module.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: Peers4PATH

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2011
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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