Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Organ Transplantation

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01370746

DAIT CTOTC-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

502 participants in 2 patient groups

Cross-Sectional Study Group

Description:

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

Description:

Subset of Cross-Sectional Study Group to evaluate whether perceived barriers to adherence increase with time during the first year following transplantation