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

NCT ID: NCT02763943

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2018-01-22

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

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Medication Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age and able to give informed consent.

2. Received a first or repeat cadaveric or living donor renal transplant.

3. 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.

4. Patient is at least one year post transplant.

5. Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.

6. Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.

7. Willing to comply with all study visits.

Exclusion Criteria

1. Biopsy proven acute rejection episode that occurred within the past month.

2. Patients who have received an organ transplant other than a kidney.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Taber DJ, Gebregziabher M, Posadas A, Schaffner C, Egede LE, Baliga PK. Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients. J Am Coll Clin Pharm. 2018 Dec;1(2):81-88. doi: 10.1002/jac5.1024. Epub 2018 Jun 21.

Reference Type: DERIVED

PMID: 30714026 (View on PubMed)

Other Identifiers

Pro00051804

Identifier Type: -

Identifier Source: org_study_id