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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02028195
• Other study ID #: Tryg 7-11-0500
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 11000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Health Promotion
• Mental Health
• Physical Inactivity
• Selfreported Quality of Health

Intervention

Other:
• Health check
The program includes four components: Invitation: All participants receive invitation by mail and a prefixed appointment time. A web-based questionnaire including self-reported health (SF12), physical activity, smoking habits and alcohol use/behaviour has to be answered before Health Examination (HE). The HE include: Blood pressure, waist, weight, lung function test, lipid profile, HbA1c and fitness (Aastrand). Health profile pamphlet: The participant receives a pamphlet with the results. The persons are stratified into three groups (I) referral to a consultation in general practice (GP) (II) targeted behavioural programs at the health centre (HC) or (III ) no identified need for health promoting follow-up. Follow-up according to risk-profile: If referred to GP treatment of risk conditions or diseases will follow national guidelines. The GPs were paid 50 Euros per health interview.

Locations

Country	Name	City	State
Denmark	Department of Public Health	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Randers Municipality, Denmark, Region MidtJylland Denmark, Tryg Danmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health economy assessment	The economic benefits of the interventions will be assessed by comparing mean direct and total costs (direct and productivity costs), and expected life years gained (LYG) in the intervention group with the control group (within a period of four.	4 years
Primary	Physical activity	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.	4 years
Primary	Modelled cardiovascular risk	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.	4 years
Primary	Health related quality of life	Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)	4 years
Primary	Functional capacity	Functional capacity will be measured as affiliation to the labor market (work participation in the last year)and sick leave > 3 weeks.	4 years