Primary Disease Prevention With the Lifestyle Tool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 90,000
- 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 via clinical registries follow the incidence and development of type 2 diabetes and cardiovascular disease in those using the tool regularly and those in the control group.
详细描述
Cardiovascular disease (CVD) and type 2 diabetes (T2D) remain leading cause of death in most European countries, and new strategies for prevention are urgently needed.
Considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes and cardiovascular disease. Modifiable lifestyle factors have been established as key drivers of disease onset and progression.
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •Age above 35 years
排除标准
- •type 1 diabetes, MODY or secondary diabetes
- •conditions or treatments that in the judgement of the Investigator could affect the study evaluation
- •connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
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.
Incidence of type 2 diabetes
时间窗: 3 yars
Incidence of type 2 diabetes defined as random plasma glucose \>11.1 mmol/L or fasting glucose \>7.0 mmol/L or HbA1C ≥6.5% compared between participants regularly using the tool and on usual care.
次要结局
未报告次要终点