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Clinical Trials/NCT05254392
NCT05254392
Completed
Not Applicable

The Impact of Pharmacists' Interventions on Blood Pressure Among Patients With Chronic Kidney Disease: a Randomized Controlled Trial

University of Maiduguri2 sites in 1 country147 target enrollmentNovember 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Maiduguri
Enrollment
147
Locations
2
Primary Endpoint
Changes in blood pressure control
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aims of the study were to determine whether pharmacists' interventions combining patient home-based self-measured BP monitoring improve blood pressure reduction and control compared with usual care in chronic kidney disease (CKD) patients

Detailed Description

This is a prospective randomized two-group pharmacist-led interventional study that was conducted in two public nephrology clinics. The study involved the introduction of pharmaceutical care to improve blood pressure and adherence to the prescribed medications among patients with chronic kidney disease (CKD). Recruited patients were randomly divided into two groups; the intervention group and the control group, with baseline evaluation of outcomes measured. The Control group was provided with usual care. An intervention group was provided in addition to the usual care, face-to-face education on CKD, hypertension as a co-morbidity and its management, and antihypertensive medication adherence at baseline (group education), 6 months and 12 months (individualized according to each patient's needs), CKD patient educational infographic leaflet at baseline, a calibrated sphygmomanometer digital blood pressure monitor (Chidalex®) for home-based self-measured BP monitoring, a BP logbook at baseline for the recording of blood pressure values daily and hands-on training on BP self-measurement. Also, antihypertensive medication adherence and home-based self-measured BP monitoring, reminder cell phone text messages were sent biweekly throughout the trial period, while phone-in inquiries from the participants and phone-out reinforcement interventions were utilized throughout the trial period. Both groups were followed for a period of 12 months.

Registry
clinicaltrials.gov
Start Date
November 12, 2019
End Date
January 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roland Nnaemeka Okoro

Principal Investigator

University of Maiduguri

Eligibility Criteria

Inclusion Criteria

  • CKD stages 1 - 4,
  • Voluntary written informed consent,
  • Willingness to abide by the rules of trial, and
  • Availability during the trial duration

Exclusion Criteria

  • Patients with acute renal failure,
  • CKD stage 5,
  • Pregnant or lactating women,
  • Post-renal transplant patients,
  • Patients with HIV infection,
  • Critically ill patients or patients known to have cognitive impairment.

Outcomes

Primary Outcomes

Changes in blood pressure control

Time Frame: 6 months and 12 months

Changes in the proportion of participants with both controlled systolic and diastolic blood pressure less than 130/80 mmHg overtime were measured

Changes in mean blood pressure

Time Frame: 6 months and 12 months

Changes in both mean systolic and diastolic blood pressure.overtime were determined

Secondary Outcomes

  • Changes in mean serum creatinine levels(6 months and 12 months)
  • Changes in mean antihypertensive medication adherence(6 months and 12 months)
  • Participants' satisfaction with care received(12 months)

Study Sites (2)

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