Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme

Not Applicable

• Conditions: Health Promotion; Physical Inactivity; Selfreported Quality of Health; Mental Health; Cardiovascular Disease
• Interventions: Other: Health check

• Registration Number: NCT02028195
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-10-01
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11000

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health check	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.

Primary Outcome Measures

Name	Time	Method
Functional capacity	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	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	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	4 years	Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)

Trial Locations

Locations (1)

Department of Public Health; 🇩🇰 Aarhus, Denmark