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Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

Completed
Conditions
Organ Transplantation
Registration Number
NCT01370746
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
502
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients1 month post transplant

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-up12 months post transplant

Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (15)

Baylor College of Medicine/Texas Children's Hospital

🇺🇸

Houston, Texas, United States

Children's Hospital of Boston

🇺🇸

Boston, Massachusetts, United States

Ronald Reagan UCLA Medical Center (Mattel Childrens')

🇺🇸

Los Angeles, California, United States

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

Emory Children's Center

🇺🇸

Atlanta, Georgia, United States

The Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

Lucile Packard Children's Hospital at Stanford

🇺🇸

Stanford, California, United States

University of Florida Health Sciences Center

🇺🇸

Gainesville, Florida, United States

Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Children's Hospital and Regional Medical Center

🇺🇸

Seattle, Washington, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Children's Hospital of New York

🇺🇸

New York, New York, United States

University of Alabama

🇺🇸

Birmingham, Alabama, United States

University of California San Francisco Children's Hospital

🇺🇸

San Francisco, California, United States

University of Pittsburgh School of Medicine

🇺🇸

Pittsburgh, Pennsylvania, United States

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