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Peers for Promoting Adolescent Transplant Health (Peers4PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450033
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : May 16, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Behavior and Behavior Mechanisms Behavioral: Peer Mentoring Behavioral: e-Communication with mentor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants
Study Start Date : September 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 29, 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450033

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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)
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Principal Investigator: Sandra Amaral, MD, MHS Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01450033    
Other Study ID Numbers: 11-008336
DK083529 ( Other Grant/Funding Number: NIDDK )
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Keywords provided by Children's Hospital of Philadelphia: