A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Difference in daytime ABPM at 6-month between TBC and usual care patients
研究概览
简要总结
The purpose of this study is to determine whether a team-based care (TBC) intervention, combining physician, nurse and pharmacist care improves BP control compared to usual care at 6 months among outpatients with uncontrolled hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treated patients with uncontrolled hypertension (defined as daytime systolic/diastolic ambulatory blood pressure monitoring (ABPM) ≥135/85mmHg) taking one or two antihypertensive medications;
- •speak and understand French;
- •agree to use the same pharmacy's services for the whole duration of the study.
排除标准
- •unable to understand the study aim;
- •pregnancy and lactating;
- •livimg in a nursing home;
- •hospitalization during the recruitment period;
- •participation in another study;
- •daytime ABPM>180/110 mmHg.
研究组 & 干预措施
Usual care
TBC intervention
A structured collaborative intervention delivered by trained nurses of ambulatory clinics and by community pharmacists working in collaboration with physicians during 6-month of follow-up includes:
- BP measurements;
- an educational and counselling intervention on patient adherence;
- an educational and counselling intervention on lifestyle (physical activity and diet).
Physicians adjust antihypertensive medications based on nurse and pharmacist feedback.
干预措施: TBC intervention (Behavioral)
结局指标
主要结局
Difference in daytime ABPM at 6-month between TBC and usual care patients
时间窗: 6-month
Difference in daytime ABPM at 6-month between TBC and usual care patients
Difference in the proportion of patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 6-month between TBC and usual care patients
时间窗: 6-month
Difference in the proportion of patients with controlled blood pressure (daytime ABPM \<135/85 mmHg) at 6-month between TBC and usual care patients
次要结局
- Difference in the proportion of TBC and usual care patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 12-month (6 months after intervention stopped)(12-month)
- Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention(6-month)
研究者
Valérie Santschi
Dr. Valérie Santschi, PharmDipl, PhD
Centre Hospitalier Universitaire Vaudois