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

NCT02763943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-02-12

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

Pharmacist-led, technology enabled education intervention

Prospective, non-randomized, pilot study assessing the feasibility and potential efficacy of a 6-month, pharmacist-led, technology enabled education intervention on improving medication safety and cardiovascular risk factor control in adult solitary kidney transplant recipients with a secondary aim of assessing if the impact of the intervention varies by race.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2018-01-22
Completion
2018-01-22

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763943 on ClinicalTrials.gov