The Ebeltoft Health Promotion Project

NCT ID: NCT00145782

Last Updated: 2005-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-09-30
• Study Completion Date: 1999-12-31

Brief 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.

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.

Conditions

Primary Prevention

Keywords

multiphasic screening; primary health care; randomized controlled trial; Risk factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Life style

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 30 to 49 1. january 1991
• Registered with a local general practitioner in the district of Ebeltoft

Exclusion Criteria

• Unable to understand and respond to a mailed invitation questionnaire

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Principal Investigators

Torsten Lauritzen, Professor

Role: STUDY_CHAIR

Institute of Public Health, Dept. of general Practice, University of Aarhus

Locations

Institute of Public Health, Dept. of General Practice, University of Aarhus

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 12100779 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15814585 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31662372 (View on PubMed)

Other Identifiers

2001-41-0738 Data Protec. A

Identifier Type: -

Identifier Source: secondary_id

9801336 Medical Res. Council

Identifier Type: -

Identifier Source: secondary_id

22-04-0434 Danish Research Ag

Identifier Type: -

Identifier Source: secondary_id

1990/1966

Identifier Type: -

Identifier Source: org_study_id