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临床试验/NCT05309876
NCT05309876招募中不适用

Secondary Prevention of Cardiovascular Disease With the Lifestyle Tool

Region Skane2 个研究点 分布在 1 个国家目标入组 11,000 人开始时间: 2022年4月6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
11,000
试验地点
2
主要终点
Incidence of major adverse cardiovascular event

研究概览

简要总结

In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively follow the incidence of major cardiovascular events in patients who have previously suffered from a myocardial infarction in those using the tool regularly and those in the control group.

详细描述

Cardiovascular disease (CVD) remains a leading cause of death in most European countries, and new strategies for prevention are urgently needed.

Previous studies on primary and secondary prevention have shown that lifestyle interventions can affect risk factors for CVD and reduce cardiovascular morbidity and mortality. Many prevention programmes are, however, time-limited and fail to provide continuous support. They also require substantial costs and healthcare resources. Furthermore, accessibility to primary and secondary cardiac prevention programmes is highly variable, as is long-term adherence to lifestyle advice.

In light of this, international associations have emphasized the need for innovative, scalable and cost-effective lifestyle interventions that could be integrated into pre-existing healthcare structures. Digital tools have large potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy is scarce. Second, most studies to date have included only small number of individuals, and there is a need for large randomized controlled studies. Third, cost-effectiveness remains to be demonstrated.

The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.

In individuals who have previously suffered from a myocardial infarction the investigators will test the hypothesis that those who access to the tool have lower incidence of further major cardiovascular events (MACE) compared with control individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 35 to 80 years
  • myocardial infarction within one year prior to enrolment
  • access to computer or mobile phone.

排除标准

  • conditions or treatments that in the judgement of the Investigator could affect the study evaluation

结局指标

主要结局

Incidence of major adverse cardiovascular event

时间窗: 3 years

Incidence of major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure compared between participants regularly using the tool and on usual care.

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 (2)

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