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临床试验/NCT03908710
NCT03908710已完成不适用

A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device

Accumbo AB2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
172
试验地点
2
主要终点
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor

研究概览

简要总结

Aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor.

详细描述

Despite the extensive knowledge of the importance of treating and thus preventing complications of hypertension, the incidence of high blood pressure is increasing, and it is still the main cause of cardiovascular disease and premature death, partly due to deficiencies in preventive care and control of the disease in an aging world. Blood pressure values obtained by self-measurement at home (HBPM) have been shown to predict the cardiovascular prognosis equally well as or better than blood pressure values obtained in the clinic (CBPM) in several observational studies. Aim of the present study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system and a electronic health record, a patient app and a home blood pressure monitor. " The patient app and the doctor's record reflect each other and basically contain the same information. Doctors can treat their patients remotely and the patients are able to manage some health issues by themselves by using the applications. Some patients need the physical examination. We therefore included patients after a so-called triage step with medical questions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary hypertension
  • Smartphone at home

排除标准

  • Secondary hypertension,
  • previous stroke,
  • myocardial infarction,
  • known heart failure,
  • known cardiac arrhytmia,
  • known servere renal failure,
  • known dementia

研究组 & 干预措施

home Home blood pressure levels in hypertensive participants

Other

Only one arm. No control group.

干预措施: Treatment of hypertension using blood pressure self-measurement at home (Other)

结局指标

主要结局

Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor

时间窗: 3 months

We investigate if the blood pressure is better in the end of the study compared with the start

Patient experience

时间窗: 3 months

We investigate how the patients experience the medical technology system and the treatment using a questionnaire

次要结局

  • Hypotension(3 months)

研究者

发起方
Accumbo AB
申办方类型
Other
责任方
Sponsor

研究点 (2)

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