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Peers for Promoting Adolescent Transplant Health (Peers4PATH)

This study is ongoing, but not recruiting participants.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia Identifier:
First received: October 6, 2011
Last updated: February 14, 2017
Last verified: February 2017
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.

Condition Intervention
Behavior and Behavior Mechanisms
Behavioral: Peer Mentoring
Behavioral: e-Communication with mentor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official Title: A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Quality of Life [ Time Frame: 1 year ]
    Health-related Quality of Life will be measured using the Peds QL Transplant Module.

Enrollment: 74
Study Start Date: September 2011
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   14 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01450033

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Sandra Amaral, MD, MHS Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01450033     History of Changes
Other Study ID Numbers: 11-008336
DK083529 ( Other Grant/Funding Number: NIDDK )
Study First Received: October 6, 2011
Last Updated: February 14, 2017

Keywords provided by Children's Hospital of Philadelphia:
liver processed this record on April 26, 2017