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Completed

NCT Number: NCT02763943

Improving Medication Safety and CVD 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:

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

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Key information

Conditions

Cardiovascular Diseases Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist-led, technology enabled education intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. Change in HBA1C values from baseline to end of study

    Time frame: 6 months

  3. Change in lipid values from baseline to end of study

    Time frame: 6 months

  4. 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

  5. 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. Number of medication errors assessed at baseline and compared to errors at 6 months

    Time frame: 6 months

  7. 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.

  8. Patient reported survey results regarding self-care and health knowledge from baseline to end of study

    Time frame: 6 months

  9. Patient reported survey results regarding psychosocial status from baseline to end of study

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2016
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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