Skip to main content
OpenTrials
Completed

NCT Number: NCT05254392

Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Specialist Hospital, Maiduguri, Borno State, Nigeria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Chronic Kidney Education, Medication adherence reminder text messages, Other tele-interventions

Primary outcomes

  1. Changes in mean blood pressure

    Time frame: 6 months and 12 months

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

  2. Changes in blood pressure control

    Time frame: 6 months and 12 months

    Changes in the proportion of participants with both controlled systolic and diastolic blood pressure less than 130/80 mmHg overtime were measured

Secondary outcomes

  1. Changes in mean antihypertensive medication adherence

    Time frame: 6 months and 12 months

    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.

  2. Changes in mean serum creatinine levels

    Time frame: 6 months and 12 months

    Participants' blood samples were analyzed for creatinine levels

  3. Participants' satisfaction with care received

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Maiduguri

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.