Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01370746

Enrollment

502

Registered

2011-06-10

Start date

2012-04-30

Completion date

2014-04-30

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Transplantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients	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	12 months post transplant	Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)

Countries

United States

Outcome results