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Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433134
First Posted: February 9, 2007
Last Update Posted: April 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
State University of New York - Downstate Medical Center
  Purpose

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:

  1. 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.
  2. A brief review of demographics and pertinent laboratory information at the same encounter

Condition Intervention
Kidney Transplantation Treatment Refusal Patient Compliance Behavioral: Adherence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survey Investigation of Adherence to Immunosuppression and Other Medications Among Kidney Transplant Recipients at SUNY Downstate

Resource links provided by NLM:


Further study details as provided by State University of New York - Downstate Medical Center:

Estimated Enrollment: 100
Study Start Date: June 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Objectives:

  1. To determine the prevalence of nonadherence in our population
  2. To assess possible causes of nonadherence and correlate those causes with demographic information and clinical findings
  3. To assess for differences between adherence with immunosuppressive regime versus adherence with other medications (for hypertension, diabetes, hypercholesterolemia)

Methods:

  1. 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
  2. A brief review of demographics and pertinent laboratory information at the same encounter
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433134


Locations
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
State University of New York - Downstate Medical Center
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
  More Information

Responsible Party: Mariana Markell, MD, SUNY Downstate MC
ClinicalTrials.gov Identifier: NCT00433134     History of Changes
Other Study ID Numbers: 06-093
First Submitted: February 7, 2007
First Posted: February 9, 2007
Last Update Posted: April 24, 2009
Last Verified: April 2009

Keywords provided by State University of New York - Downstate Medical Center:
renal transplant recipient
adherence
compliance
immunosuppression