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

NCT02028195 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11000

Last updated 2018-10-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tryg Danmark

    collaborator UNKNOWN
  • Randers Municipality, Denmark

    collaborator OTHER
  • Region MidtJylland Denmark

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Annelli Sandbæk, Professor · University of Aarhus

  • Helle T Maindal, Professor · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028195 on ClinicalTrials.gov