Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)
研究概览
简要总结
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
详细描述
This study will be a prospective, open-label, randomized 1-to-1 and monocentric trial, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France.
The patients will be recruited during their visit at the day hospitalization of the Diagnosis and Therapeutic Center of Hôtel-Dieu University Hospital, for hypertension-related complications and cardiovascular risk assessment as part of their hypertension management.
Randomization/allocation will be conducted at the last moment before scheduling appointments.
The "usual care" group will keep a traditional follow-up: day hospitalization then consultation with a MD within approximately 2 to 12 months.
The "intervention" group will meet the APN between the day hospitalization and the MD consultation, within 1 to 6 months (Figure 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •at least 18 years of age,
- •treated or untreated hypertension,
- •can to provide a written informed consent.
排除标准
- •age under 18 years old,
- •inability to give a free informed consent.
结局指标
主要结局
Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)
时间窗: 12 months
According to the European and International guidelines, the protocol for office BP measurement will be: 5 minutes rest, 3 measurements at one-minute intervals in supine position followed by 3 standing measurements at one-minute intervals for orthostatic hypotension test. Unattended office blood pressure measurement will be conducted thanks to a supervisor (usually a nurse) who will explain the protocol to the patient before letting him rest in a quiet room and thanks to an automatic sphygmomanometer that can print the statement of measures at the end of the monitoring. Blood pressure level will be estimated by the average of the 2 last blood pressure measures in supine position. We will consider that blood pressure is controlled if systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg.
次要结局
- Indication(s) of therapeutic adjustments during the APN intervention(6 months)
- Difference in rates of controlled blood pressure (office blood pressure < 140/90 mmHg) between day hospitalization and MD consultation in each group.(12 months)
- Rate of home blood pressure monitoring brought to MD consultation(12 months)
- Rate of therapeutic adjustments during the APN intervention(6 months)
- Quality of the home blood pressure monitoring brought to MD consultation(12 months)
研究者
Jacques Blacher
MD, PhD
Hotel Dieu University Hospital, France