Clinical trial NCT02763943: Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients
Official title: Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes Mellitus
Medication Adherence
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Change in blood pressure values from baseline to end of study
timeFrame: 6 months
measure: Change in HBA1C values from baseline to end of study
timeFrame: 6 months
measure: Change in lipid values from baseline to end of study
timeFrame: 6 months
measure: Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention
timeFrame: 1 year
measure: Patient self-reported medication adherence at baseline compared to end of study.
timeFrame: 6 months
measure: Number of medication errors assessed at baseline and compared to errors at 6 months
timeFrame: 6 months
measure: Medication side effects at baseline compared to end of study.
timeFrame: 6 months
measure: Patient reported survey results regarding self-care and health knowledge from baseline to end of study
timeFrame: 6 months
measure: Patient reported survey results regarding psychosocial status from baseline to end of study
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.