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Clinical Trials/NCT01859273
NCT01859273
Completed
Not Applicable

Adherence Enhancement for Renal Transplant Patients

Medical University of South Carolina1 site in 1 country18 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Failure
Sponsor
Medical University of South Carolina
Enrollment
18
Locations
1
Primary Endpoint
medication adherence
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
August 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John W. McGillicuddy

Associate Professor of Surgery

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • Persons \> 21 years of age
  • first time recipient of a solitary kidney transplant
  • prescribed at least 3 medications for immunosuppression and hypertension
  • previous history of non-adherence
  • functioning kidney transplant
  • ability to speak, hear and understand English
  • able to use medication delivery device and self administer medications
  • able to operate blood pressure monitor
  • comfortable using cell phone
  • no other diagnosis that might shorten lifespan

Exclusion Criteria

  • failure to meet all inclusion criteria

Outcomes

Primary Outcomes

medication adherence

Time Frame: 5 months

adherence to immunosuppressive medications

Secondary Outcomes

  • blood pressure(5 months)

Study Sites (1)

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