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临床试验/NCT03554382
NCT03554382已完成不适用

PERson-centredness in Hypertension Management Using Information Technology (PERHIT) Study

Region Skane4 个研究点 分布在 1 个国家目标入组 971 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
971
试验地点
4
主要终点
Change in blood pressure

研究概览

简要总结

Background:

Hypertension is an increasing global problem and measures are needed against the emerging hypertensive burden. Management of the risk factor hypertension consists of medical treatment in conjunction with lifestyle adjustment, whereby lifestyle adjustment is the preventive cornerstone but has also been proven to contribute to BP reduction among those already receiving medical drug treatments. Non-adherence is a significant barrier to successful hypertension management.

Goal:

To improve management of hypertension in daily life from a person-centred perspective, utilizing information and communication technology, and further to decrease complications of hypertension. To increase the proportion of persons with hypertension obtaining a BP goal =<140/90 mmHg and to conduct a health economic evaluation of our intervention.

Plan:

The investigators will conduct a multi-centre randomized controlled trial in 36 primary care centres in three counties in Sweden. There will be approximaely 430 patients in each group. BP will be measured in a standardized manner, laboratory tests taken and questionnaires answered at baseline, after eight weeks and after a year in both the intervention and the control group. Register data on health care resource one year before baseline and for the full study period will be retrieved for participants in both study groups.

Singificance:

The intervention is expected to improve adherence to treatment and a significant lowering of the blood pressure. Hospitalization rates are lower among persons with hypertension that adheres to their medication. By improving treatment of hypertension the hope is to decrease complications and morbidity due to hypertension and thereby hospitalization and health care costs. Due to the generic nature of the technology involved, the self-management system can easily be adapted to monitor other chronic conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Age 18 years or older
  • Diagnosis of hypertension
  • On treatment with at least one antihypertensive drug
  • Understanding of Swedish in order to be able to provide informed consent and to make use of the mobile phone based self-management support system.
  • Mobile phone (patients will use their own mobile, but have the possibility to borrow one if needed)
  • Patient at a primary healthcare centre in any of four participating healthcare regions in Sweden (Skåne, Västra Götaland, Östergötland, and Jönköping)

排除标准

  • Secondary hypertension
  • Terminal illness
  • Pregnancy-induced hypertension
  • Cognitive impairment
  • Impaired vision (not able to read messages on mobile phone)
  • Psychotic disease

结局指标

主要结局

Change in blood pressure

时间窗: 12 months

mean of three BP Readings at each timepoint

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (4)

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