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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Aarhus
Sponsor:
Collaborators:
Tryg Danmark
Municipality of Randers
Region MidtJylland Denmark
Information provided by (Responsible Party):
Annelli Sandbæk, University of Aarhus
ClinicalTrials.gov Identifier:
NCT02028195
First received: December 13, 2013
Last updated: July 3, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Physical activity [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)

  • Functional capacity [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years to 49 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Municipality of Randers
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

No publications provided

Responsible Party: Annelli Sandbæk, Professor, University of Aarhus
ClinicalTrials.gov Identifier: NCT02028195     History of Changes
Other Study ID Numbers: Tryg 7-11-0500
Study First Received: December 13, 2013
Last Updated: July 3, 2014
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014