Chronic Kidney Diseases
Conditions
Keywords
Blood pressure, Chronic Kidney Disease, Home blood pressure self-monitoring, Nigeria, Pre-dialysis, Pharmacists' interventions
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.
Interventions
DEVICEDigital 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.
Sponsors
University of Maiduguri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mean blood pressure | 6 months and 12 months | Changes in both mean systolic and diastolic blood pressure.overtime were determined |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Changes in mean serum creatinine levels | 6 months and 12 months | Participants' blood samples were analyzed for creatinine levels |
| 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. |
Countries
Nigeria
Outcome results
None listed