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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Annelli Sandbæk, University of Aarhus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02028195
First Posted: January 7, 2014
Last Update Posted: July 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tryg Danmark
Randers Municipality, Denmark
Region MidtJylland Denmark
Information provided by (Responsible Party):
Annelli Sandbæk, University of Aarhus
  Purpose
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.

Condition Intervention
Health Promotion Cardiovascular Disease Physical Inactivity Selfreported Quality of Health Mental Health Other: Health check

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by Annelli Sandbæk, University of Aarhus:

Primary Outcome Measures:
  • 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)

  • 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.


Other Outcome Measures:
  • Health economy assessment [ Time Frame: 4 years ]
    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.


Estimated Enrollment: 11000
Study Start Date: May 2013
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

No Intervention: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028195


Contacts
Contact: Annelli Sandbæk, Professor +45 2128 2073 annelli.sandbaek@alm.au.dk
Contact: Helle M Terkildsen, Ass Professsor +45 25462320 htm@alm.au.dk

Locations
Denmark
Department of Public Health, Section of General Practice Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Annelli Sandbæk, Professor         
Sponsors and Collaborators
University of Aarhus
Tryg Danmark
Randers Municipality, Denmark
Region MidtJylland Denmark
Investigators
Principal Investigator: Annelli Sandbæk, PhD Professor Department of Public Health, Århus University
Principal Investigator: Helle T Maindal, PhD, Associate Professor Department of Public Health, University of Aarhus
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annelli Sandbæk, Professor, University of Aarhus
ClinicalTrials.gov Identifier: NCT02028195     History of Changes
Other Study ID Numbers: Tryg 7-11-0500
First Submitted: December 13, 2013
First Posted: January 7, 2014
Last Update Posted: July 4, 2014
Last Verified: July 2014

Keywords provided by Annelli Sandbæk, University of Aarhus:
Health check
Health promotion
prevention diabetes
prevention cardiovascular disease
mental health

Additional relevant MeSH terms:
Cardiovascular Diseases