Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme
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| ClinicalTrials.gov Identifier: NCT02028195 |
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Recruitment Status : Unknown
Verified September 2018 by Annelli Sandbæk, University of Aarhus.
Recruitment status was: Enrolling by invitation
First Posted : January 7, 2014
Last Update Posted : October 1, 2018
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Sponsor:
University of Aarhus
Collaborators:
Tryg Danmark
Randers Municipality, Denmark
Region MidtJylland Denmark
Information provided by (Responsible Party):
Annelli Sandbæk, University of Aarhus
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Health Promotion Cardiovascular Disease Physical Inactivity Selfreported Quality of Health Mental Health | Other: Health check | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 11000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | May 2013 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2019 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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Primary Outcome Measures :
- 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.
Other Outcome Measures:
- 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.
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| Ages Eligible for Study: | 30 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028195
Locations
| Denmark | |
| Department of Public Health | |
| Aarhus, Denmark, 8000 | |
Sponsors and Collaborators
University of Aarhus
Tryg Danmark
Randers Municipality, Denmark
Region MidtJylland Denmark
Investigators
| Principal Investigator: | Annelli Sandbæk, Professor | University of Aarhus | |
| Principal Investigator: | Helle T Maindal, Professor | University of Aarhus |
Study Documents (Full-Text)
Documents provided by Annelli Sandbæk, University of Aarhus:
Documents provided by Annelli Sandbæk, University of Aarhus:
Statistical Analysis Plan [PDF] August 21, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Annelli Sandbæk, Professor, University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT02028195 |
| Other Study ID Numbers: |
Tryg 7-11-0500 |
| First Posted: | January 7, 2014 Key Record Dates |
| Last Update Posted: | October 1, 2018 |
| Last Verified: | September 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Annelli Sandbæk, University of Aarhus:
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Health check Health promotion prevention diabetes prevention cardiovascular disease mental health |
Additional relevant MeSH terms:
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Cardiovascular Diseases |