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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation in Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Sweet, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Lara Danziger-Isakov, MD, MPH | Children's Hospital Medical Center, Cincinnati | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Ronald Reagan UCLA Medical Center (Mattel Childrens') |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26799519 | Background | 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. | |
| 26670870 | Result | 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. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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| 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 |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Clinical Trials in Organ Transplantation in Children (CTOT-C) | View source |