Clinical trial NCT01370746: Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation
Official title: Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Transplantation
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation in Children
First posted: 2011-06-10
Enrollment: 502
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)

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.

Eligibility 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

Primary outcomes:
measure: Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients
timeFrame: 1 month post transplant
measure: Change in perceived barriers to adherence from baseline to follow-up
timeFrame: 12 months post transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center (Mattel Childrens')
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Children's Hospital
state: California
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
city: Gainesville
country: United States
facility: University of Florida Health Sciences Center
state: Florida
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Children's Hospital of New York
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Stuart Sweet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lara Danziger-Isakov, MD, MPH
role: STUDY_CHAIR
References:
citation: Shemesh E. Barriers to adherence - To screen or not to screen, that is the question. Pediatr Transplant. 2016 Mar;20(2):188-90. doi: 10.1111/petr.12671. Epub 2016 Jan 22. No abstract available.
citation: Danziger-Isakov L, Frazier TW, Worley S, Williams N, Shellmer D, Dharnidharka VR, Gupta NA, Ikle D, Sweet SC; CTOTC-05 Consortium. Perceived barriers to medication adherence in pediatric and adolescent solid organ transplantation. Pediatr Transplant. 2016 Mar;20(2):307-15. doi: 10.1111/petr.12648. Epub 2015 Dec 16.