Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Device: Digital BP monitor (Chidalex®)

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.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Borno
    • Maiduguri, Borno, Nigeria, 600230
      • State Specialist Hospital
    • Maiduguri, Borno, Nigeria, 600230
      • University of Maiduguri Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants in the UC arm received the usual/conventional care offered by the hospitals which included: hospital visits on appointment or a sick day, consultations with the physicians, prescription of drugs and routine laboratory tests, review of diagnosis and medications, refilling of prescriptions by patients and referral.
Experimental: Pharmacists' Intervention; Participants in the PI arm received routine usual care plus pharmacists' interventions for 12 months. The PI arm received usual care plus 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 BP monitor (Chidalex®) for HSMBM, a BP logbook at baseline for the recording of BP values daily and hands-on training on BP self-measurement. Also, antihypertensive medication adherence and HSMBM 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	Device: Digital BP monitor (Chidalex®); Interventions were provided in groups of 4 - 10 participants after data collection at baseline while reinforcing individualized interventions were provided during subsequent visits to the research clinic for follow-up at 6 months and 12 months. Medication reminder text messages were delivered to each participant biweekly.; Other Names: Chronic Kidney Education; Medication adherence reminder text messages; Other tele-interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean blood pressure	Changes in both mean systolic and diastolic blood pressure.overtime were determined	6 months and 12 months
Changes in blood pressure control	Changes in the proportion of participants with both controlled systolic and diastolic blood pressure less than 130/80 mmHg overtime were measured	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean antihypertensive medication adherence	Antihypertensive medication adherence was determined using the 4-item Morisky-Green-Levine (MGL) scale. The response was scored as follows: a "yes" response was scored one point and zero to a "no" response. The total score ranged from zero to four. Adherence levels were then categorized into three based on the total score. Zero, 1 - 2, and 3 - 4 were classified as high adherence, moderate adherence, and low adherence, respectively. Lower scores mean a better outcome.	6 months and 12 months
Changes in mean serum creatinine levels	Participants' blood samples were analyzed for creatinine levels	6 months and 12 months
Participants' satisfaction with care received	The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ) 2.0 (Sakharkar et al., 2015) was used to assess patient satisfaction with care received. The participants' responses to items 1-19 were scored 4 points, 3 points, 2 points, and 1 point, respectively for "strongly agreed", "agree", "disagree", and "strongly disagree". However, item 20 was also scored 4 points, 3 points, 2 points, and 1 point, respectively for "exceeded your expectation", "met your expectation", "did not meet your expectation", and "I had no expectation". For the quality of care domain, minimum value is 1 and maximum value is 40, For interpersonal relationship domain, minimum value is 1 and maximum value is 24. For overall satisfaction domain, minimum value is 1 and maximum value is 16.Higher scores mean a better outcome.	12 months

Collaborators and Investigators

• Sponsor: University of Maiduguri
• Investigators: Principal Investigator: Roland N Okoro, PhD, University of Maiduguri

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Blood pressure; Nigeria; Pre-dialysis; Home blood pressure self-monitoring; Pharmacists' interventions
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: PharmBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No