Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254392
• Other study ID #: PharmBP
• Status: Completed
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2022
• Source: University of Maiduguri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Nigeria	State Specialist Hospital	Maiduguri	Borno
Nigeria	University of Maiduguri Teaching Hospital	Maiduguri	Borno

Sponsors (1)

Lead Sponsor	Collaborator
University of Maiduguri

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean blood pressure	Changes in both mean systolic and diastolic blood pressure.overtime were determined	6 months and 12 months
Primary	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	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
Secondary	Changes in mean serum creatinine levels	Participants' blood samples were analyzed for creatinine levels	6 months and 12 months
Secondary	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