Drug Compliance of Patients With Uncontrolled Hypertension Under Treatment: a Pilot Study (Descriptive, Prospective, Monocentric Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- individual pattern of drug compliance
研究概览
简要总结
Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.
In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.
For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.
Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.
Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •patient treated with diuretics and / or beta-blockers and / or calcium-blockers and / or ACE inhibitors and / or sartans
- •Holter blood pressure total average of 24h greater than 135/85 mmHg or a daytime average greater than 140/90 mmHg or a nighttime average greater than 125/75 mmHg.
- •informed consent given
排除标准
- •Adults with severe hypertension (BP ≥ 180/110 mmHg) with or without organ failure requiring therapeutic adaptation
- •Adults unable to comply with study procedures
- •Patients who do not wish to receive generic drugs.
结局指标
主要结局
individual pattern of drug compliance
时间窗: 2 months of follow-up
compliance measurement using electronic monitoring devices
次要结局
- Percentage of Prescribed Dosing Days with Correct Intake(2 months of follow-up)
- Percentage of Drug Holidays(2 months of follow-up)
- Time Variability in Drug Intake(2 months of follow-up)
- Percentage of Prescribed Dose Taken(2 months of follow-up)