The Impact of Pharmacists' Interventions on Blood Pressure Among Patients With Chronic Kidney Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Changes in blood pressure control
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants were blinded to the profession of the investigators and study arms, while outcome assessors were blinded to the interventions and study arms.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stages 1 - 4,
- •Voluntary written informed consent,
- •Willingness to abide by the rules of trial, and
- •Availability during the trial duration
排除标准
- •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.
结局指标
主要结局
Changes in blood pressure control
时间窗: 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
时间窗: 6 months and 12 months
Changes in both mean systolic and diastolic blood pressure.overtime were determined
次要结局
- Changes in mean serum creatinine levels(6 months and 12 months)
- Changes in mean antihypertensive medication adherence(6 months and 12 months)
- Participants' satisfaction with care received(12 months)
研究者
Roland Nnaemeka Okoro
Principal Investigator
University of Maiduguri