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Clinical Trials/NCT02028195
NCT02028195
Unknown
Not Applicable

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 site in 1 country11,000 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Promotion
Sponsor
University of Aarhus
Enrollment
11000
Locations
1
Primary Endpoint
Functional capacity
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Annelli Sandbæk

Professor

University of Aarhus

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Terminal illness, reported by their GP is exclusion criteria for receiving invitation.

Outcomes

Primary Outcomes

Functional capacity

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 4 years

Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)

Study Sites (1)

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