Primary Prevention Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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