The CORE-trial: a Pragmatic Randomized Controlled Trial in Primary Care Investigating Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme Offered Population-wide to 30-49 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 11,000
- 试验地点
- 1
- 主要终点
- Functional capacity
研究概览
简要总结
Check your health is a prevention intervention designed to create awareness and action on health condition with focus at physical activity at a population-level to 30-49 years of age. It consists of a behavioural and clinical examination followed by either (I) referral to a health promoting consultation in general practice (II) targeted behavioural programmes at the local Health Centre or (III ) no need for follow-up; stratified after risk-profile. The CORE trial (Check your health) aim to investigate effectiveness on health and social outcomes of the preventive health check and to establish the cost-effectiveness according to life years gained; direct costs and total health costs. A pragmatic cluster randomised controlled trial has been established to meet the aims and in total 10.600 individuals from 35 practices have been randomized in to two groups that will be invited in 2013-14 and 2017-18 respectively. The group offered the preventive health check in 2013-14 will constitute the intervention group and the group examined in 2017 - 18 the control group. A follow up of the intervention group in 2017 - 18 will provide data for the intention to treat analysis revealing the effect. Outcome measures are level of physical activity, risk of getting cardiovascular disease, sick leave and labor market attachment.
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
- 30 Years 至 49 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all citizens living in Randers Municipality aged 30-49 on 1 January 2012, identified in the Danish Civil Registers (DCR) and randomised for health check in 2013 or 2017.
排除标准
- •Terminal illness, reported by their GP is exclusion criteria for receiving invitation.
研究组 & 干预措施
Health check
The intervention consists of invitation for a behavioural and clinical examination followed by either (I) referral to a health promoting consultation in general practice (II) targeted behavioural programmes at the local Health Centre or (III ) no need for follow-up.
干预措施: Health check (Other)
No invitation
The persons randomised to the control arm does not get invitation to a health care examination before time for follow up in the intervention group.
结局指标
主要结局
Functional capacity
时间窗: 4 years
Functional capacity will be measured as affiliation to the labor market (work participation in the last year)and sick leave \> 3 weeks.
Physical activity
时间窗: 4 years
Physical activity level will be measured by 1) self-reported physical activity (days/week with minimum 30 minutes moderate physical activity) and 2) physical fitness, measured by Aastrands submaximal bike-test.
Modelled cardiovascular risk
时间窗: 4 years
Cardiovascular risk will be measured as a modelled risk of developing cardiovascular disease within 10 years and includes information on age, gender, smoking status, systolic blood pressure and total cholesterol.
Health related quality of life
时间窗: 4 years
Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)
次要结局
未报告次要终点
研究者
Annelli Sandbæk
Professor
University of Aarhus
