Clinical trial NCT05254392: Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease
Official title: The Impact of Pharmacists' Interventions on Blood Pressure Among Patients With Chronic Kidney Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Blood pressure
Chronic Kidney Disease
Home blood pressure self-monitoring
Nigeria
Pre-dialysis
Pharmacists' interventions
Lead sponsor: University of Maiduguri
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Changes in mean blood pressure
timeFrame: 6 months and 12 months
measure: Changes in blood pressure control
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Changes in mean antihypertensive medication adherence
timeFrame: 6 months and 12 months
measure: Changes in mean serum creatinine levels
timeFrame: 6 months and 12 months
measure: Participants' satisfaction with care received
timeFrame: 12 months
Other outcomes:
Locations:
city: Maiduguri
country: Nigeria
facility: State Specialist Hospital
state: Borno
city: Maiduguri
country: Nigeria
facility: University of Maiduguri Teaching Hospital
state: Borno
Study officials:
affiliation: University of Maiduguri
name: Roland N Okoro, PhD
role: PRINCIPAL_INVESTIGATOR
References: