NCT01450033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

5.3 years

First QC Date

October 6, 2011

Last Update Submit

May 11, 2018

Conditions

Behavior and Behavior Mechanisms

Keywords

kidneyrenaltransplanttransplantationadolescentpediatricmentormentoringmedicationadherenceimmunosuppressantheartliver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mentoring mechanisms

    1 year

  • Quality of Life

    1 year

Study Arms (2)

Control group

NO INTERVENTION

Standard of care

Mentoring group

EXPERIMENTAL

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 MentoringBehavioral: e-Communication with mentor

Interventions

Peer MentoringBEHAVIORAL

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.

Mentoring group
e-Communication with mentorBEHAVIORAL

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

Mentoring group

Eligibility Criteria

Age14 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

  • Sandra Amaral, MD, MHS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 12, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2017

Study Completion

March 29, 2017

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

US(1)