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临床试验/NCT06580613
NCT06580613招募中不适用

Sustainable Hypertension Management in Primary Health Care in Sweden - Ett hållbart omhändertagande av Blodtryckspatienter i primärvården

Region Skane1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
500
试验地点
1
主要终点
Blood pressure change

研究概览

简要总结

New sustainable models of patient-focused and team-based care for patients with hypertension should be developed to achieve health improvements and cost-efficiency.

The aim of this project is to evaluate new ways of sustainable hypertension (HT) management in primary care, starting with a pilot study at 2 Primary Health Care Centres (PHCCs).

At intervention PHCCs cardiovascular risk is assessed with SCORE2 for all hypertension patients. The staff receives education on HT treatment and an easy-to-follow treatment protocol. Non-physicians lead patient education on HT in groups. Patients receive a home blood pressure (BP) monitor and communicate digitally with the assigned nurse on medication update, blood and urinary tests and follow up. The nurse consults with the physician if needed. Regular face to face visits with the physician are only scheduled for patients with high cardiovascular risk or end organ damage, otherwise for all patients if needed.

At the control PHCs hypertension care continues as usual. All participants will be asked to complete questionnaires after 6 and 24 months.

Outcomes are feasibility for the pilot study and the proportion of patients reaching BP target plus change in systolic BP, cardiovascular risk factors, patients´ and staff´s grade of satisfaction and knowledge, and health care costs for the main study, compared between intervention and control PHCCS. Results will help to establish sustainable models of treating HT patients in Primary Care.

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

性别
All
接受健康志愿者

入选标准

  • Adult patients with hypertension

排除标准

  • secondary hypertension according to the medical records at the Primary Health Care Center
  • terminal illness
  • pregnancy-induced hypertension
  • cognitive impairment
  • impaired vision (not able to read measurements for the home BP measurements or communicate via "1177 direct" digitally)
  • psychotic disorder

结局指标

主要结局

Blood pressure change

时间窗: 24 months

change in proportion of patients reaching blood pressure target of \<140/90 mmHg

次要结局

  • Health economic evaluation(24 months)
  • Participants grade of satisfaction(24 months)
  • Staffs grade of satisfaction(24 months)
  • Blood glucose level and cholesterol(24 months)
  • Kidney function(24 months)
  • Kidney complications(24 months)
  • Smoking(24 months)

研究者

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

研究点 (1)

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