NCT00433134

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 24, 2009

Status Verified

April 1, 2009

Enrollment Period

1 year

First QC Date

February 7, 2007

Last Update Submit

April 23, 2009

Conditions

Kidney TransplantationTreatment RefusalPatient Compliance

Keywords

renal transplant recipientadherencecomplianceimmunosuppression

Interventions

AdherenceBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Less than 6 months post-transplant
  • More than 4.5 years post transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Treatment RefusalPatient Compliance

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPatient Acceptance of Health Care

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2007

First Posted

February 9, 2007

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 24, 2009

Record last verified: 2009-04

Locations

US(1)