Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

June 1, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)

In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine.

Study Overview

Status

Completed

Conditions

Detailed Description

Adhering to treatment regimens after solid organ transplantation is critical for the prevention of complications, including acute and chronic organ rejection. It is important to recognize the perceived barriers to following treatment regimens and identify ways to address these barriers early in the course of treatment.

Study Type

Observational

Enrollment (Actual)

502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • California
      • Los Angeles, California, United States, 90095-1752
        • Ronald Reagan UCLA Medical Center (Mattel Childrens')
      • San Francisco, California, United States, 94143
        • University of California San Francisco Children's Hospital
      • Stanford, California, United States, 94305
        • Lucile Packard Children's Hospital at Stanford
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health Sciences Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital of Boston
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • Children's Hospital of New York
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Texas Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105-0371
        • Children's Hospital and Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)

Description

Inclusion Criteria:

  • Subject and/or guardian must be able to understand and provide informed consent/assent in English or Spanish
  • Male or female primary solid organ transplant patients 0-21 years of age
  • Recipients at least 1 month post-transplant hospital discharge

Exclusion Criteria:

  • Inability or unwillingness of a participant or parent/guardian to give informed consent or comply with study protocol
  • Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the questionnaires
  • Re-transplant recipient
  • Multi-organ transplant recipient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cross-Sectional Study Group
Cross-sectional comparison of perceived barriers to adherence to post-transplant immunosuppressant regimens in parents/legal guardians of children 0-11 years versus adolescents 12-21 years
Longitudinal Study Group
Subset of Cross-Sectional Study Group to evaluate whether perceived barriers to adherence increase with time during the first year following transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients
Time Frame: 1 month post transplant
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
1 month post transplant
Change in perceived barriers to adherence from baseline to follow-up
Time Frame: 12 months post transplant
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
12 months post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Clinical Trials in Organ Transplantation in Children

Investigators

  • Principal Investigator: Stuart Sweet, MD, PhD, Washington University School of Medicine
  • Study Chair: Lara Danziger-Isakov, MD, MPH, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DAIT CTOTC-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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