Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

NCT05254392 | Completed

• 1 other identifier: PharmBP
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Kidney Diseases

Keywords

Blood pressure; Chronic Kidney Disease; Home blood pressure self-monitoring; Nigeria; Pre-dialysis; Pharmacists' interventions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in mean antihypertensive medication adherence

  6 months and 12 months

• Changes in mean serum creatinine levels

  6 months and 12 months

• Participants' satisfaction with care received

  12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Pharmacists' Intervention

EXPERIMENTAL

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

Digital BP monitor (Chidalex®) DEVICE

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.

Also known as: Chronic Kidney Education, Medication adherence reminder text messages, Other tele-interventions

Pharmacists' Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maiduguri: lead

Study Sites (2)

State Specialist Hospital

Maiduguri, Borno State, 600230, Nigeria

Location

University of Maiduguri Teaching Hospital

Maiduguri, Borno State, 600230, Nigeria

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland N Okoro, PhD

  University of Maiduguri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to the profession of the investigators and study arms, while outcome assessors were blinded to the interventions and study arms.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 24, 2022
• Study Start: November 12, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (2)