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Clinical Trials/NCT02763943
NCT02763943
Completed
Not Applicable

Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients

Medical University of South Carolina1 site in 1 country60 target enrollmentApril 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Medical University of South Carolina
Enrollment
60
Locations
1
Primary Endpoint
Change in lipid values from baseline to end of study
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings.

This pilot study is to:

  1. Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
  2. Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study
  3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study
  4. Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
  5. Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients
Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
January 22, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age and able to give informed consent.
  • Received a first or repeat cadaveric or living donor renal transplant.
  • Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
  • Patient is at least one year post transplant.
  • Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
  • Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
  • Willing to comply with all study visits.

Exclusion Criteria

  • Biopsy proven acute rejection episode that occurred within the past month.
  • Patients who have received an organ transplant other than a kidney.

Outcomes

Primary Outcomes

Change in lipid values from baseline to end of study

Time Frame: 6 months

Number of medication errors assessed at baseline and compared to errors at 6 months

Time Frame: 6 months

Change in blood pressure values from baseline to end of study

Time Frame: 6 months

Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.

Change in HBA1C values from baseline to end of study

Time Frame: 6 months

Medication side effects at baseline compared to end of study.

Time Frame: 6 months

The Memphis side effect scale will be used to compare side effects from baseline to end of study.

Patient reported survey results regarding self-care and health knowledge from baseline to end of study

Time Frame: 6 months

Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention

Time Frame: 1 year

Patient self-reported medication adherence at baseline compared to end of study.

Time Frame: 6 months

The Morisky 8-item adherence score will be compared from baseline to end of study.

Patient reported survey results regarding psychosocial status from baseline to end of study

Time Frame: 6 months

Study Sites (1)

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