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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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.

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.

  1. Cardiovascular risk profile after 5 and 15 years

  2. Life years gained and cost effectiveness after 6 years

  3. 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.

  1. First posted5 Sep 2005 (estimated)
  2. Study startSep 1991
  3. Study completionDec 1999

Resources

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)
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 12100779
  • Thomsen 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 15814585
  • Bernstorff 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

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.

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