Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease
- Conditions
- Chronic Kidney Diseases
- Interventions
- Device: Digital BP monitor (Chidalex®)
- Registration Number
- NCT05254392
- Lead Sponsor
- University of Maiduguri
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- CKD stages 1 - 4,
- Voluntary written informed consent,
- Willingness to abide by the rules of trial, and
- Availability during the trial duration
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacists' Intervention Digital BP monitor (Chidalex®) 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
- Primary Outcome Measures
Name Time Method Changes in blood pressure control 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
Changes in mean blood pressure 6 months and 12 months Changes in both mean systolic and diastolic blood pressure.overtime were determined
- Secondary Outcome Measures
Name Time Method Changes in mean serum creatinine levels 6 months and 12 months Participants' blood samples were analyzed for creatinine levels
Changes in mean antihypertensive medication adherence 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.
Participants' satisfaction with care received 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.
Trial Locations
- Locations (2)
University of Maiduguri Teaching Hospital
🇳🇬Maiduguri, Borno, Nigeria
State Specialist Hospital
🇳🇬Maiduguri, Borno, Nigeria