Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation
This study is currently recruiting participants.
Verified November 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01370746
First received: June 8, 2011
Last updated: November 14, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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. 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.
| Condition |
|---|
|
Organ Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05) |
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients [ Time Frame: 1 month post transplant ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months post transplant ] [ Designated as safety issue: No ]Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370746
Locations
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Stephanie Clevenger 205-558-2792 sclevenger@peds.uab.edu | |
| Principal Investigator: Dan Feig, MD | |
| United States, California | |
| Mattel Children's Hospital University of California Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095-1752 | |
| Contact: Maggie Holloway 310-206-8415 mholloway@mednet.ucla.edu | |
| Principal Investigator: Eileen Tsai, MD | |
| University of California San Francisco Children's Hospital | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Stephanie Lemp 415-476-9657 LempS@peds.ucsf.edu | |
| Principal Investigator: Marsha Lee, MD | |
| Lucile Packard Children's Hospital at Stanford | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Elisabeth Merkel 650-736-0644 merkel@stanford.edu | |
| Principal Investigator: Carol Conrad, MD | |
| United States, Florida | |
| University of Florida Health Sciences Center | Terminated |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| Emory Children's Center | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Monica Haughton 404-785-0421 Monica.haughton@choa.org | |
| Principal Investigator: Nitika Gupta, MD | |
| United States, Massachusetts | |
| Children's Hospital of Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Leslie Spaneas, RN, MPH 617-355-8314 leslie.spaneas@childrens.harvard.edu | |
| Principal Investigator: William Harmon, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Colleen Eisenbarger 314-747-0791 Eisenbarger_c@wustl.edu | |
| Principal Investigator: Stuart Sweet, MD, PhD | |
| United States, New York | |
| Children's Hospital of New York | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Rose Rodriguez 212-305-6575 rc687@columbia.edu | |
| Principal Investigator: Linda Addonizio, MD | |
| United States, Ohio | |
| The Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Donna Lach, RN 216-444-5034 lachd@ccf.org | |
| Principal Investigator: Johanna Goldfarb, MD | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Ashley Nance 614-722-6359 ashley.nance@nationwidechildrens.org | |
| Principal Investigator: Don Hayes, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Rosa Kim 267-426-7161 kimr1@email.chop.edu | |
| Principal Investigator: Samuel Goldfarb, MD | |
| University of Pittsburgh School of Medicine | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Jane Luce 412-692-6762 jane.luce@chp.edu | |
| Principal Investigator: Steven Webber, MDChB, MRCP | |
| United States, Texas | |
| Baylor College of Medicine/Texas Children's Hospital | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Nicoline Schaap 832-822-4252 nxschaap@texaschildrens.org | |
| Principal Investigator: Mark Schecter, MD | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center | Recruiting |
| Seattle, Washington, United States, 98105-0371 | |
| Contact: Robert Johnson 206-884-7863 robert.johnson@seattlechildrens.org | |
| Contact: Jennifer McDonald (206) 987-5477 Jennifer.mcdonald@seattlechildrens.org | |
| Principal Investigator: Ruth McDonald, MD | |
| Principal Investigator: Jodi Smith, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Stuart Sweet, MD, PhD | Washington University in St. Louis |
| Study Chair: | Lara Danziger-Isakov, MD, MPH | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01370746 History of Changes |
| Other Study ID Numbers: | DAIT CTOTC-05 |
| Study First Received: | June 8, 2011 |
| Last Updated: | November 14, 2012 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on May 23, 2013