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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763943
• Other study ID #: Pro00051804
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: February 9, 2018
• Start date: April 1, 2016
• Est. completion date: January 22, 2018

Study information

• Verified date: April 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure values from baseline to end of study	Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.	6 months
Primary	Change in HBA1C values from baseline to end of study		6 months
Primary	Change in lipid values from baseline to end of study		6 months
Primary	Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention		1 year
Primary	Patient self-reported medication adherence at baseline compared to end of study.	The Morisky 8-item adherence score will be compared from baseline to end of study.	6 months
Primary	Number of medication errors assessed at baseline and compared to errors at 6 months		6 months
Primary	Medication side effects at baseline compared to end of study.	The Memphis side effect scale will be used to compare side effects from baseline to end of study.	6 months
Primary	Patient reported survey results regarding self-care and health knowledge from baseline to end of study		6 months
Primary	Patient reported survey results regarding psychosocial status from baseline to end of study		6 months