Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

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.

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Key information

Conditions

Organ Transplantation

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)
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)

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

Clinical Trials in Organ Transplantation in Children

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 10, 2011
Registry last updated: Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed