The Ebeltoft Health Promotion Project

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00145782
First received: September 1, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Primary Prevention
Behavioral: Life style
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Ebeltoft Health Promotion Project - A Randomized Controlled Trial With Multiphasic Preventive Health Screenings and Discussions in General Practice.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cardiovascular risk profile after 5 and 15 years
  • Life years gained and cost effectiveness after 6 years
  • All cause mortality after 15 years

Study Start Date: September 1991
Estimated Study Completion Date: December 1999
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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145782

Locations
Denmark
Institute of Public Health, Dept. of General Practice, University of Aarhus
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Torsten Lauritzen, Professor Institute of Public Health, Dept. of general Practice, University of Aarhus
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00145782     History of Changes
Other Study ID Numbers: 1990/1966, 2001–41–0738 Data Protec. A, 9801336 Medical Res. Council, 22-04-0434 Danish Research Ag
Study First Received: September 1, 2005
Last Updated: September 1, 2005
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
multiphasic screening
primary health care
randomized controlled trial
Risk factors

ClinicalTrials.gov processed this record on July 28, 2014