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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Trials in Organ Transplantation in Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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