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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00433134
Other study ID # 06-093
Secondary ID
Status Completed
Phase N/A
First received February 7, 2007
Last updated April 23, 2009
Start date June 2006
Est. completion date June 2007

Study information

Verified date April 2009
Source State University of New York - Downstate Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Behavioral:
Adherence


Locations

Country Name City State
United States SUNY Downstate Medical Center Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

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