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

September 27, 2018 updated by: Annelli Sandbæk, University of Aarhus

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

11000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years
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.
4 years
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)
4 years
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.
4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Region MidtJylland Denmark
Tryg Danmark
Randers Municipality, Denmark

Investigators

  • Principal Investigator: Annelli Sandbæk, Professor, University of Aarhus
  • Principal Investigator: Helle T Maindal, Professor, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tryg 7-11-0500

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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