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

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ClinicalTrials.gov Identifier: NCT00433134
Recruitment Status : Completed
First Posted : February 9, 2007
Last Update Posted : April 24, 2009
Sponsor:
Information provided by:
State University of New York - Downstate Medical Center

Brief Summary:

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 or disease Intervention/treatment
Kidney Transplantation Treatment Refusal Patient Compliance Behavioral: Adherence

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

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survey Investigation of Adherence to Immunosuppression and Other Medications Among Kidney Transplant Recipients at SUNY Downstate
Study Start Date : June 2006
Primary Completion Date : June 2007
Study Completion Date : June 2007

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U.S. FDA Resources





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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

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

Responsible Party: Mariana Markell, MD, SUNY Downstate MC
ClinicalTrials.gov Identifier: NCT00433134     History of Changes
Other Study ID Numbers: 06-093
First Posted: February 9, 2007    Key Record Dates
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