Peers for Promoting Adolescent Transplant Health (Peers4PATH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Hospital of Philadelphia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sandra Amaral, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01450033
First received: October 6, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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 Phase
Behavior and Behavior Mechanisms
Behavioral: Peer Mentoring
Behavioral: e-Communication with mentor
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Health-related Quality of Life will be measured using the Peds QL Transplant Module.


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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.

  Eligibility

Ages Eligible for Study:   14 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01450033

Contacts
Contact: Sandra Amaral, MD, MHS 267-426-1451 amarals@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sandra Amaral, MD, MHS    267-426-1452    amarals@email.chop.edu   
Principal Investigator: Sandra Amaral, MD, MHS         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Sandra Amaral, MD, MHS Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Sandra Amaral, Principal Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01450033     History of Changes
Other Study ID Numbers: 11-008336, DK083529
Study First Received: October 6, 2011
Last Updated: April 21, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
kidney
renal
transplant
transplantation
adolescent
pediatric
mentor
mentoring
medication
adherence
immunosuppressant
heart
liver

ClinicalTrials.gov processed this record on October 20, 2014