NCT02028195

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

5.6 years

First QC Date

December 13, 2013

Last Update Submit

September 27, 2018

Conditions

Health PromotionCardiovascular DiseasePhysical InactivitySelfreported Quality of HealthMental Health

Keywords

Health checkHealth promotionprevention diabetesprevention cardiovascular diseasemental health

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Health related quality of life

    Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)

    4 years

  • 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

Other Outcomes (1)

  • Health economy assessment

    4 years

Study Arms (2)

Health check

EXPERIMENTAL

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

No invitation

NO INTERVENTION

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.

Interventions

Health checkOTHER

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.

Health check

Eligibility Criteria

Age30 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health

Aarhus, 8000, Denmark

Location

Related Publications (4)

  • Bjerregaard AL, Dalsgaard EM, Bruun NH, Norman K, Witte DR, Stovring H, Maindal HT, Sandbaek A. Effectiveness of the population-based 'check your health preventive programme' conducted in a primary care setting: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2022 Jan;76(1):24-31. doi: 10.1136/jech-2021-216581. Epub 2021 Jun 18.

    PMID: 34145078DERIVED

  • Geyti C, Christensen KS, Dalsgaard EM, Bech BH, Gunn J, Maindal HT, Sandbaek A. Factors associated with non-initiation of mental healthcare after detection of poor mental health at a scheduled health check: a cohort study. BMJ Open. 2020 Oct 16;10(10):e037731. doi: 10.1136/bmjopen-2020-037731.

    PMID: 33067280DERIVED

  • Geyti C, Dalsgaard EM, Sandbaek A, Maindal HT, Christensen KS. Initiation and cessation of mental healthcare after mental health screening in primary care: a prospective cohort study. BMC Fam Pract. 2018 Nov 17;19(1):176. doi: 10.1186/s12875-018-0864-9.

    PMID: 30447688DERIVED

  • Maindal HT, Stovring H, Sandbaek A. Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial. Trials. 2014 Aug 29;15:341. doi: 10.1186/1745-6215-15-341.

    PMID: 25169211DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesSedentary BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Officials

  • Annelli Sandbæk, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

  • Helle T Maindal, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2013

First Posted

January 7, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

DK(1)