- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02763943
Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients
Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients
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:
- Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
- 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
- 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
- Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
- Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years of age and able to give informed consent.
- Received a first or repeat cadaveric or living donor renal transplant.
- 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.
- Patient is at least one year post transplant.
- Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
- Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
- Willing to comply with all study visits.
Exclusion Criteria:
- Biopsy proven acute rejection episode that occurred within the past month.
- Patients who have received an organ transplant other than a kidney.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure values from baseline to end of study
Time Frame: 6 months
|
Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
|
6 months
|
Change in HBA1C values from baseline to end of study
Time Frame: 6 months
|
6 months
|
|
Change in lipid values from baseline to end of study
Time Frame: 6 months
|
6 months
|
|
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention
Time Frame: 1 year
|
1 year
|
|
Patient self-reported medication adherence at baseline compared to end of study.
Time Frame: 6 months
|
The Morisky 8-item adherence score will be compared from baseline to end of study.
|
6 months
|
Number of medication errors assessed at baseline and compared to errors at 6 months
Time Frame: 6 months
|
6 months
|
|
Medication side effects at baseline compared to end of study.
Time Frame: 6 months
|
The Memphis side effect scale will be used to compare side effects from baseline to end of study.
|
6 months
|
Patient reported survey results regarding self-care and health knowledge from baseline to end of study
Time Frame: 6 months
|
6 months
|
|
Patient reported survey results regarding psychosocial status from baseline to end of study
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00051804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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