Impact of Self-monitoring of Blood Pressure and Self-titration of Antihypertensive Medication in the Control of Hypertension and Adherence to Treatment. A Pragmatic, Randomized, Controlled Clinical Trial (ADAMPA Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Mean systolic blood pressure (SBP).
研究概览
简要总结
The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the effectiveness of an intervention based on self-monitoring and self-titration of medication in poorly controlled hypertensive patients 40 years and older. The total duration of the study is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and control groups).
详细描述
ADAMPA study. Objectives: To evaluate the comparative effectiveness of an intervention that includes educational components, self-monitoring of blood pressure and self-titration of antihypertensive medication in the improvement of control of hypertension compared to usual care in a poorly controlled population of hypertensive patients.
Design: Pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms.
Disease related to the study: Hypertension.
Main outcome measure: Difference in mean systolic blood pressure, in mmHg. At 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer
Study population: Patients assigned to the Valencia Clinic-La Malvarrosa Health Department. Total number of patients to be randomized: 458 (229 per arm).
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years or older
- •Diagnosis of hypertension of any origin
- •Systolic blood pressure (SBP) > 145 or diastolic blood pressure (DBP) > 90 mm Hg at baseline
- •Voluntarily participation in the study and having signed the corresponding informed consent.
排除标准
- •Inability to understand and/or perform self-adjustment of the medication, including dementia or significant cognitive impairment (at the discretion of the investigator performing the recruitment).
- •History of orthostatic hypotension (fall> 20 mm Hg in SBP after adopting the orthostatic position).
- •SBP> 200 or DBP> 100 mm Hg on the baseline examination
- •Being on treatment with more than 4 antihypertensive drugs
- •Participation in another study on high blood pressure or in a clinical trial
- •Presence of tremor or neurological disease that makes it difficult to perform BP self-measurement.
- •Presence of arrhythmia
- •Presence of terminal illness
- •Chronic disability impeding to leave home
- •History of acute cardiovascular event in the last 3 months
- •Hypertension managed directly by specialist physicians outside the primary care setting.
- •Spouse selected for the study
- •Non-resident or transient patients
- •Pregnancy
研究组 & 干预措施
Self-monitoring/Self-titration
The intervention consists of self-monitoring blood pressure at home, and subsequent medication self-titration, based on a medication adjustment plan pre-established by the family physician, in patients with uncontrolled hypertension.
干预措施: Self-monitoring/Self-titration (Other)
Routine care
Patients in this arm will receive routine care for high blood pressure in the primary health care center.
结局指标
主要结局
Mean systolic blood pressure (SBP).
时间窗: 12 months from start of intervention
Difference in mean systolic blood pressure, in mmHg. At 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer
次要结局
- Mean systolic blood pressure at 6 and 24 months(6 and 24 months)
- Mean diastolic blood pressure (DBP) at 6 and 24 months(6 and 24 months)
- EuroQoL-5D score(6,12,24 months)
- Percentage of patients with normal SBP and DBP(6,12, 24 months)
- Medication persistence(12 months)
- Medication adherence(12 months)
- Therapeutic inertia(6,12,24 months)
研究者
José Sanfelix
Primary Care Physician
Fundación para la Investigación del Hospital Clínico de Valencia