NCT03963934终止不适用
Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
Mme Edith DAUCHY1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年10月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.
研究概览
简要总结
This study evaluate the feasibility of a 6-month personalized support program for hypertensive and non-observant women, led by nurses by telephone follow-up.
详细描述
The program includes 2 themes:
- "Realizing my blood pressure self-measurement" according to the recommendations
- "Optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking
Visits :
- Inclusion visit :
- Collection of consent by the nurse
- Verification of inclusion and non-inclusion criteria : measurement of compliance with a scale for each antihypertensive treatment and BP measurement
- Data collection and goal setting
- Urine collection for dosing anti-hypertension drugs
- Delivery of the schedule of telephone visits that were determined with the patient
- Implementation of personalized support with the following steps :
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 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman ≥ 18 to 79 years old,
- •Hypertensive and treated with antihypertensive drug(s)
- •Unsatisfactory compliance for at least one of her antihypertensive treatment with a score below 80% at the medication adherence scale
- •Uncontrolled Blood Pressure (BP) : systolic BP equals to or greater than140 and / or diastolic BP equals to or greater than 90 mmHg at inclusion visit
- •Informed consent signed
- •Affiliation to a French social security scheme or beneficiary of such a scheme
排除标准
- •Patient with a history of cardio or cerebrovascular disease in the last 6 months (Stroke or Transient Ischemic Attack, myocardial infarction, heart failure)
- •Patient with kidney failure requiring dialysis
- •Patient with cognitive pathology: dementia, ... etc.
- •Patient with type I diabetes
- •Unreachable patient by phone or foreseeable inability or unwillingness to comply with study follow-up
- •Patient who does not understand and does not speak French
研究组 & 干预措施
Women with uncontrolled hypertension
Experimental
Women with uncontrolled hypertension and unsatisfactory medication adherence
干预措施: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention (Other)
结局指标
主要结局
Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.
时间窗: 6 months
The goal of recruitment in 6 months will be 20 women and the goal of the program finalization will be of at least 80% of patients (16 patients).
次要结局
未报告次要终点
研究者
Mme Edith DAUCHY
Mme
Central Hospital, Nancy, France
研究点 (1)
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