Health PromotionNCT02028195
Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme
A study testing Health check in people with Health Promotion and Cardiovascular Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Promotion, Cardiovascular Disease, Physical Inactivity
- What is being tested?
- Health check
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,000 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Terminal illness, reported by their GP is exclusion criteria for receiving invitation.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Health Promotion, Cardiovascular Disease, Physical Inactivity, Selfreported Quality of Health, Mental Health
- Being tested
- Health check
- Keywords
- Health check, Health promotion, prevention diabetes, prevention cardiovascular disease, mental health
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 years
Health related quality of life
Health related quality of life measured by The Medical Outcome Study Short Form 12 Health Survey (SF12)
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Tryg Danmark, Randers Municipality, Denmark, Region MidtJylland Denmark
- Responsible party
- Principal investigator, Annelli Sandbæk, University of Aarhus
- Investigators
- Annelli Sandbæk, Professor, Principal investigator, University of AarhusHelle T Maindal, Professor, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028195
- Sponsor's protocol ID
- Tryg 7-11-0500
- Status last verified
- Sep 2018
- First submitted
- 13 Dec 2013
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34145078Geyti 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.
PubMed 33067280Geyti 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.
PubMed 30447688Maindal 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.
PubMed 25169211
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02028195
- Acronym / sponsor ID
- Tryg 7-11-0500
- Conditions
- Health Promotion, Cardiovascular Disease, Physical Inactivity, Selfreported Quality of Health, Mental Health
- Keywords
- Health check, Health promotion, prevention diabetes, prevention cardiovascular disease, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Tryg Danmark, Randers Municipality, Denmark, Region MidtJylland Denmark
- Study start
- May 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health check | Experimental | Other: Health checkThe 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. |
| 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. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Terminal illness, reported by their GP is exclusion criteria for receiving invitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health checkThe 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. | Other | Health check |
Primary outcome
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.
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.
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)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Derived from this study: PubMed 34145078Bjerregaard 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.
- Derived from this study: PubMed 33067280Geyti 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.
- Derived from this study: PubMed 30447688Geyti 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.
- Derived from this study: PubMed 25169211Maindal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelli Sandbæk, Professor principal investigator
University of Aarhus
Helle T Maindal, Professor principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health check in people with Health Promotion and Cardiovascular Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02028195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2018.