The Föllinge Hypertension and Lifestyle Intervention; a Comparative Study of Methods for Blood Pressure Measurement and Survey of Living Habits
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Comparative measurement of blood pressure
研究概览
简要总结
Ambulatory blood pressure measurement is more demanding in terms of technical equipment and specially trained staff. If blood pressure measurement in a self-care room is on average equivalent to the ambulatory blood pressure daytime monitoring of hypertension in primary care could be simplified. We therefore want to examine patients monitored for hypertension (ICD 10) with three different methods: conventional blood pressure measurement in office, self-directed automated measurement and ambulatory blood pressure, starting in December 2020. We will also offer an interview covering cardiovascular risk factors, at time for enrollment and after 6 months. The study was approved to include 150 adult study patients (The swedish ethical review authority 2020-01375), men and women, where diagnosis and treatment of hypertension is relevant after a clinical evaluation.
详细描述
Background: At present, both 24-hour ambulatory blood pressure and self-directed blood pressure measurement in self-care rooms, are services provided by most Swedish primary care clinics. Ambulatory measurement of blood pressure has the disadvantage of being more demanding with regard to the need for advanced technical equipment and trained staff.
Identification of modifiable cardiovascular risk factors and support for change, should be integrated into the treatment programs of hypertension. At study entry all study participants will be invited to an interview focused on identifying modifiable cardiovascular risk factors, with a follow-up interview after six months to consolidate good lifestyle choices.
Aim: If self-directed blood pressure measured in a designated self-care room gives results that are on average equivalent to ambulatory blood pressure daytime, diagnosis and follow-up of hypertensive patients in primary care could be simplified. The majority of patients could then be cared for through self-checks., and the technically more demanding ambulatory blood pressure measurement reserved for special cases. We therefore want to examine patients under treatment or investigated for hypertension in primary care with three different methods: conventional in-office blood pressure measurement by medical staff, ambulatory blood pressure and automated measurement of blood pressure in a special self-care room. Between study entry and after six months changes in modifiable risk factors are documented according to an interview guide covering use of tobacco, alcohol, physical activity and food preferences, with 4-6 fixed alternatives per item.
Demographics: Study patients are recruited among patients registered at Föllinge Health Centre (population 1500), of which about 1000 are in ages where investigation and treatment of hypertension could be relevant. The prevalence of hypertension in the adult population is estimated to about 30%.
Methods: We will recruit men and women from age 20 and older. Advanced age is not a criterion for exclusion if treatment of hypertension is judged to be important after clinical assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 years or older
- •investigated or treated because of essential hypertension
- •registered at Föllinge Health Centre
排除标准
- •patients in need of emergency care
- •advanced stages of disease or dementia
- •not able to perform self-directed blood pressure measurement
- •pregnancy
- •atrial fibrillation
- •arm circumference to small or wide for device
- •non consenting
- •re entry in same study
结局指标
主要结局
Comparative measurement of blood pressure
时间窗: Hours 24
Systolic and diastolic pressure, in office, self directed and ambulatory
次要结局
- Assessment of modifiable cardiovascular risk factors(Months 6)
