Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01370746
First received: June 8, 2011
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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. 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.


Condition
Organ Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients [ Time Frame: 1 month post transplant ] [ Designated as safety issue: No ]
    Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)

  • Change in perceived barriers to adherence from baseline to follow-up [ Time Frame: 12 months post transplant ] [ Designated as safety issue: No ]
    Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)


Enrollment: 502
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01370746

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

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01370746     History of Changes
Other Study ID Numbers: DAIT CTOTC-05
Study First Received: June 8, 2011
Last Updated: May 30, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 30, 2014