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

NCT ID: NCT02028195

Last Updated: 2018-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

11000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Health Promotion Cardiovascular Disease Physical Inactivity Selfreported Quality of Health Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Health check

Intervention Type OTHER

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 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tryg Danmark

UNKNOWN

Sponsor Role collaborator

Randers Municipality, Denmark

OTHER

Sponsor Role collaborator

Region MidtJylland Denmark

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Annelli Sandbæk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annelli Sandbæk, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Helle T Maindal, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Department of Public Health

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34145078 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33067280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30447688 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25169211 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Tryg 7-11-0500

Identifier Type: -

Identifier Source: org_study_id

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