Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation
1 other identifier
observational
502
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 5, 2017
June 1, 2017
2 years
June 8, 2011
June 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
1 month post transplant
Change in perceived barriers to adherence from baseline to follow-up
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
12 months post transplant
Study Arms (2)
Cross-Sectional Study Group
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
Subset of Cross-Sectional Study Group to evaluate whether perceived barriers to adherence increase with time during the first year following transplantation
Eligibility Criteria
Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama
Birmingham, Alabama, 35233, United States
Ronald Reagan UCLA Medical Center (Mattel Childrens')
Los Angeles, California, 90095-1752, United States
University of California San Francisco Children's Hospital
San Francisco, California, 94143, United States
Lucile Packard Children's Hospital at Stanford
Stanford, California, 94305, United States
University of Florida Health Sciences Center
Gainesville, Florida, 32610, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Children's Hospital of Boston
Boston, Massachusetts, 02115, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Children's Hospital of New York
New York, New York, 10032, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15224, United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371, United States
Related Publications (2)
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.
PMID: 26799519BACKGROUNDDanziger-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.
PMID: 26670870RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Sweet, MD, PhD
Washington University School of Medicine
- STUDY CHAIR
Lara Danziger-Isakov, MD, MPH
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 10, 2011
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 5, 2017
Record last verified: 2017-06