Primary PreventionPhase 3NCT00145782
The Ebeltoft Health Promotion Project
A Phase 3 study testing Life style in people with Primary Prevention, run by University of Aarhus at 1 site in Denmark.
Trial summary
The objective of The Ebeltoft Health Promotion Project is investigate the effect of multiphasic preventive health screenings and discussions with general practitioners of a random population of patients in primary care. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Life style
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Sep 1991to Dec 1999
- Phase
- Phase 3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 30 to 49 1. january 1991
- Registered with a local general practitioner in the district of Ebeltoft
Who cannot join
- Unable to understand and respond to a mailed invitation questionnaire
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Public Health, Dept. of General Practice, University of Aarhus
Aarhus, DK-8000
About this study
Official title: The Ebeltoft Health Promotion Project - A Randomized Controlled Trial With Multiphasic Preventive Health Screenings and Discussions in General Practice.
The objective of The Ebeltoft Health Promotion Project is investigate the effect of multiphasic preventive health screenings and discussions with general practitioners of a random population of patients in primary care.
Outcome parameters are the cardiovascular risk profile, number of health care contacts, life years gained, direct costs, i.e. health care costs, and total cost, i.e. including productivity costs.
Read the detailed description
The Ebeltoft project was designed as a randomized controlled trial in the district of Ebeltoft, Aarhus County, Denmark. All nine general practitioners (GPs) from the four primary care units in the district participated. All patients listed in the primary care units between 30 and 49 years of age by January 1, 1991 (N=3,464) were identified in the Danish Civil Registration system, each Danish resident has a ten digit number, through which personal data can be extracted from the health and social registries. A random selection of 2,030 of the 3,464 persons was sampled for invitation to participate in the study. Those who agreed to participate were randomly divided into one control group and two intervention groups (A and B). Randomization of subjects into control and intervention groups was stratified by primary care unit, sex, age, body mass index (BMI), and cohabitation status as stated by the subjects in the invitation questionnaire. Invited subjects received an invitation questionnaire in September 1991. All subjects who agreed to participate also received questionnaires about their health, health beliefs, and social and demographic status at baseline and after one and five years. Subjects in the two intervention groups were offered a broad (multiphasic) health screening at baseline and after one and five years. After five years all subjects received a questionnaire and an invitation to a health screening and consultation. From December 1, 1991 to October 1, 1997 specially trained laboratory technicians carried out health screenings that included evaluations of cardiovascular, pulmonary, liver and kidney function, endocrine dysfunction, BMI, physical endurance, hearing and sight. Evaluation of cardiovascular function included a calculation of cardiovascular risk score (CRS), giving an estimate of the risk of premature cardiovascular disease for each individual. CRS was based on sex, familial inheritance (number of family members with ischemic heart disease before age 55), tobacco consumption, blood pressure, total serum cholesterol, and BMI.1 Within three weeks of the screenings, all participants received a written letter from their GP explaining the tests. Targeted life style counsels were included in the letter if the test results were outside a predefined range. All subjects who had been informed that they had an elevated or high CRS were encouraged to see their GP, regardless of their intervention status. After the health screenings, the subjects in group B were invited to attend a 45-minute patient centred health consultation with their GP. The health consultations were aimed primarily at discussing lifestyle-related health problems and giving the subject an opportunity to define up to three goals relating to lifestyle changes.
We investigate the impact of the intervention on the cardiovascular risk profile, number of health care contacts, the direct and total costs, and the health effects by comparing mean costs and expected life years gained of the intervention groups with those of the control group.
- Conditions
- Primary Prevention
- Being tested
- Life style
- Keywords
- multiphasic screening, primary health care, randomized controlled trial, Risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life styleBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk profile after 5 and 15 years
Life years gained and cost effectiveness after 6 years
All cause mortality after 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startSep 1991
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Torsten Lauritzen, Professor, Study chair, Institute of Public Health, Dept. of general Practice, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145782
- Sponsor's protocol ID
- 1990/1966
- Other IDs
- 2001-41-0738 Data Protec. A, 9801336 Medical Res. Council, 22-04-0434 Danish Research Ag
- Status last verified
- Sep 2005
- First submitted
- 1 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Publications
Engberg M, Christensen B, Karlsmose B, Lous J, Lauritzen T. General health screenings to improve cardiovascular risk profiles: a randomized controlled trial in general practice with 5-year follow-up. J Fam Pract. 2002 Jun;51(6):546-52.
PubMed 12100779Thomsen JL, Parner ET, Karlsmose B, Thulstrup AM, Lauritzen T, Engberg M. Effect of preventive health screening on long-term primary health care utilization. A randomized controlled trial. Fam Pract. 2005 Jun;22(3):242-8. doi: 10.1093/fampra/cmi007. Epub 2005 Apr 6.
PubMed 15814585Bernstorff M, Deichgraeber P, Bruun NH, Dalsgaard EM, Fenger-Gron M, Lauritzen T. A Randomised Trial Examining Cardiovascular Morbidity and All-Cause Mortality 24 years Following General Health Checks: the Ebeltoft Health Promotion Project (EHPP). BMJ Open. 2019 Oct 28;9(10):e030400. doi: 10.1136/bmjopen-2019-030400.
PubMed 31662372
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ebeltoft Health Promotion Project - A Randomized Controlled Trial With Multiphasic Preventive Health Screenings and Discussions in General Practice.
- ClinicalTrials.gov ID
- NCT00145782
- Acronym / sponsor ID
- 1990/1966
- Conditions
- Primary Prevention
- Keywords
- multiphasic screening, primary health care, randomized controlled trial, Risk factors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 1991
- Study completion
- Dec 1999
- First posted
- 5 Sep 2005 (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.
The objective of The Ebeltoft Health Promotion Project is investigate the effect of multiphasic preventive health screenings and discussions with general practitioners of a random population of patients in primary care.
Outcome parameters are the cardiovascular risk profile, number of health care contacts, life years gained, direct costs, i.e. health care costs, and total cost, i.e. including productivity costs.
Detailed description
The Ebeltoft project was designed as a randomized controlled trial in the district of Ebeltoft, Aarhus County, Denmark. All nine general practitioners (GPs) from the four primary care units in the district participated. All patients listed in the primary care units between 30 and 49 years of age by January 1, 1991 (N=3,464) were identified in the Danish Civil Registration system, each Danish resident has a ten digit number, through which personal data can be extracted from the health and social registries. A random selection of 2,030 of the 3,464 persons was sampled for invitation to participate in the study. Those who agreed to participate were randomly divided into one control group and two intervention groups (A and B). Randomization of subjects into control and intervention groups was stratified by primary care unit, sex, age, body mass index (BMI), and cohabitation status as stated by the subjects in the invitation questionnaire. Invited subjects received an invitation questionnaire in September 1991. All subjects who agreed to participate also received questionnaires about their health, health beliefs, and social and demographic status at baseline and after one and five years. Subjects in the two intervention groups were offered a broad (multiphasic) health screening at baseline and after one and five years. After five years all subjects received a questionnaire and an invitation to a health screening and consultation. From December 1, 1991 to October 1, 1997 specially trained laboratory technicians carried out health screenings that included evaluations of cardiovascular, pulmonary, liver and kidney function, endocrine dysfunction, BMI, physical endurance, hearing and sight. Evaluation of cardiovascular function included a calculation of cardiovascular risk score (CRS), giving an estimate of the risk of premature cardiovascular disease for each individual. CRS was based on sex, familial inheritance (number of family members with ischemic heart disease before age 55), tobacco consumption, blood pressure, total serum cholesterol, and BMI.1 Within three weeks of the screenings, all participants received a written letter from their GP explaining the tests. Targeted life style counsels were included in the letter if the test results were outside a predefined range. All subjects who had been informed that they had an elevated or high CRS were encouraged to see their GP, regardless of their intervention status. After the health screenings, the subjects in group B were invited to attend a 45-minute patient centred health consultation with their GP. The health consultations were aimed primarily at discussing lifestyle-related health problems and giving the subject an opportunity to define up to three goals relating to lifestyle changes.
We investigate the impact of the intervention on the cardiovascular risk profile, number of health care contacts, the direct and total costs, and the health effects by comparing mean costs and expected life years gained of the intervention groups with those of the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 30 to 49 1. january 1991
- Registered with a local general practitioner in the district of Ebeltoft
Key exclusion criteria (1 listed)
- Unable to understand and respond to a mailed invitation questionnaire
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 |
|---|---|---|
| Life style | Behavioural | – |
Primary outcome
Cardiovascular risk profile after 5 and 15 years
Life years gained and cost effectiveness after 6 years
All cause mortality after 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2005.
- Results publication: PubMed 12100779Engberg M, Christensen B, Karlsmose B, Lous J, Lauritzen T. General health screenings to improve cardiovascular risk profiles: a randomized controlled trial in general practice with 5-year follow-up. J Fam Pract. 2002 Jun;51(6):546-52.
- Results publication: PubMed 15814585Thomsen JL, Parner ET, Karlsmose B, Thulstrup AM, Lauritzen T, Engberg M. Effect of preventive health screening on long-term primary health care utilization. A randomized controlled trial. Fam Pract. 2005 Jun;22(3):242-8. doi: 10.1093/fampra/cmi007. Epub 2005 Apr 6.
- Derived from this study: PubMed 31662372Bernstorff M, Deichgraeber P, Bruun NH, Dalsgaard EM, Fenger-Gron M, Lauritzen T. A Randomised Trial Examining Cardiovascular Morbidity and All-Cause Mortality 24 years Following General Health Checks: the Ebeltoft Health Promotion Project (EHPP). BMJ Open. 2019 Oct 28;9(10):e030400. doi: 10.1136/bmjopen-2019-030400.
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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.
Torsten Lauritzen, Professor study chair
Institute of Public Health, Dept. of general Practice, 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 Phase 3 study testing Life style in people with Primary Prevention, 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 2 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: finished, as of the sponsor's last update on 5 Sep 2005. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular risk profile after 5 and 15 years. The study lists 3 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 NCT00145782, which also lists 3 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 5 Sep 2005.