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Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Digital BP monitor (Chidalex®)
Sponsored by
University of Maiduguri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases focused on measuring Blood pressure, Chronic Kidney Disease, Home blood pressure self-monitoring, Nigeria, Pre-dialysis, Pharmacists' interventions

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • State Specialist Hospital
  • University of Maiduguri Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Pharmacists' Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Changes in mean serum creatinine levels
Participants' blood samples were analyzed for creatinine levels
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.

Full Information

First Posted
February 5, 2022
Last Updated
February 23, 2022
Sponsor
University of Maiduguri
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1. Study Identification

Unique Protocol Identification Number
NCT05254392
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maiduguri

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Blood pressure, Chronic Kidney Disease, Home blood pressure self-monitoring, Nigeria, Pre-dialysis, Pharmacists' interventions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants were blinded to the profession of the investigators and study arms, while outcome assessors were blinded to the interventions and study arms.
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Pharmacists' Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Digital BP monitor (Chidalex®)
Other Intervention Name(s)
Chronic Kidney Education, Medication adherence reminder text messages, Other tele-interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in mean blood pressure
Description
Changes in both mean systolic and diastolic blood pressure.overtime were determined
Time Frame
6 months and 12 months
Title
Changes in blood pressure control
Description
Changes in the proportion of participants with both controlled systolic and diastolic blood pressure less than 130/80 mmHg overtime were measured
Time Frame
6 months and 12 months
Secondary Outcome Measure Information:
Title
Changes in mean antihypertensive medication adherence
Description
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.
Time Frame
6 months and 12 months
Title
Changes in mean serum creatinine levels
Description
Participants' blood samples were analyzed for creatinine levels
Time Frame
6 months and 12 months
Title
Participants' satisfaction with care received
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland N Okoro, PhD
Organizational Affiliation
University of Maiduguri
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Specialist Hospital
City
Maiduguri
State/Province
Borno
ZIP/Postal Code
600230
Country
Nigeria
Facility Name
University of Maiduguri Teaching Hospital
City
Maiduguri
State/Province
Borno
ZIP/Postal Code
600230
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

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