Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02763943
Enrollment
60
Registered
2016-05-05
Start date
2016-04-01
Completion date
2018-01-22
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Diabetes Mellitus, Medication Adherence

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

Interventions

BEHAVIORALPharmacist-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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure values from baseline to end of study6 monthsBlood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
Change in HBA1C values from baseline to end of study6 months
Change in lipid values from baseline to end of study6 months
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention1 year
Patient self-reported medication adherence at baseline compared to end of study.6 monthsThe Morisky 8-item adherence score will be compared from baseline to end of study.
Number of medication errors assessed at baseline and compared to errors at 6 months6 months
Medication side effects at baseline compared to end of study.6 monthsThe 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 study6 months
Patient reported survey results regarding psychosocial status from baseline to end of study6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026