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临床试验/NCT02028195
NCT02028195Unknown不适用

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

University of Aarhus1 个研究点 分布在 1 个国家目标入组 11,000 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

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

Experimental

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

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annelli Sandbæk

Professor

University of Aarhus

研究点 (1)

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