- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00433134
Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients
April 23, 2009 updated by: State University of New York - Downstate Medical Center
Survey Investigation of Adherence to Immunosuppression and Other Medications Among Kidney Transplant Recipients at SUNY Downstate
Goal:
To define the causes and issues associated with nonadherence in our population
Hypothesis:
There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients
Methods:
- A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence.
- A brief review of demographics and pertinent laboratory information at the same encounter
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Objectives:
- To determine the prevalence of nonadherence in our population
- To assess possible causes of nonadherence and correlate those causes with demographic information and clinical findings
- To assess for differences between adherence with immunosuppressive regime versus adherence with other medications (for hypertension, diabetes, hypercholesterolemia)
Methods:
- A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence
- A brief review of demographics and pertinent laboratory information at the same encounter
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Brooklyn, New York, United States, 11203
- SUNY Downstate Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All renal transplant recipients with a working transplant who are currently attending the transplant clinic and who have been transplanted 6 months to 4.5 years ago are eligible. Patients are recruited at random from the transplant clinic waiting area
Exclusion Criteria:
- Less than 6 months post-transplant
- More than 4.5 years post transplant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mariana Markell, MD, State University of New York - Downstate Medical Center
- Principal Investigator: Sima Terebelo, MPH, RPA-C, State University of New York - Downstate Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
February 7, 2007
First Submitted That Met QC Criteria
February 8, 2007
First Posted (Estimate)
February 9, 2007
Study Record Updates
Last Update Posted (Estimate)
April 24, 2009
Last Update Submitted That Met QC Criteria
April 23, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 06-093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.