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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Medication Adherence; Cardiovascular Diseases

• Registration Number: NCT02763943
• Lead Sponsor: Medical University of South Carolina

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-03-14
• Status Verified: 2016-04
• Study Start: 2016-04-01
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-22
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in lipid values from baseline to end of study	6 months
Number of medication errors assessed at baseline and compared to errors at 6 months	6 months
Change in HBA1C values from baseline to end of study	6 months
Change in blood pressure values from baseline to end of study	6 months	Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
Medication side effects at baseline compared to end of study.	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	6 months
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention	1 year
Patient self-reported medication adherence at baseline compared to end of study.	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	6 months

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States