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Completed

NCT Number: NCT02719678

Epidemiological Studies of Health Effects of General Examinations

The effect of systematic health examinations and screening of the general population is under debate. Recently, a large Danish randomized study found that systematic screening of risk factors and lifestyle advice in the general population did not have a preventive effect on coronary heart disease, stroke or all-cause mortality. However, there are still very few completed randomized studies, and the effect on other diseases remains unclear. The purpose is to investigate whether repeated health examinations with screening of various risk factors in an unselected population prevent long-term incidence of ischemic heart disease, stroke, total and cause-specific mortality, diabetes, dementia, chronic obstructive pulmonary disease and various forms of cancer. A preliminary protocol was submitted and approved by the Danish Data Protection Agency before the registry-based data on primary and secondary outcomes were received by the investigator.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Centre for Prevention and Health

Copenhagen, Glostrup, DK-2600, Denmark

About this study

Introduction The effect of systematic health examinations and screening of the general population is under debate. Recently, a large Danish randomized study found that systematic screening of risk factors and lifestyle advice in the general population did not have a preventive effect on coronary heart disease, stroke or all-cause mortality. However, there are still very few completed randomized studies, and the effect on other diseases remains unclear.

Purpose The purpose is to investigate whether repeated health examinations with screening of various risk factors in an unselected population prevent long-term incidence of ischemic heart disease, stroke, total and cause-specific mortality, diabetes, dementia, chronic obstructive pulmonary disease and various forms of cancer.

Research question Can health examinations with screening of various risk factors prevent the long-term incidence of ischemic heart disease, stroke, total and cause-specific mortality, diabetes, dementia, chronic obstructive pulmonary disease and various forms of cancer?

Data and method For the Danish Monica1 study, a random sample of the general population (adults) in Copenhagen County in 1982 and 1983 was extracted, consisting of a total of 17,845 people. These individuals were randomly divided into two groups, one group was offered a general medical examination while participating in the study, while the control group was not invited and remained unaware of the intervention. The intervention was thus an examination with measuring of e.g., blood pressure, cholesterol level and body mass index as well as subsequent conversation with a nurse. Participants were invited 3 times at 5-year intervals. Data from the intervention group (4,807 people) and the control group (13,038 persons) will be linked to register data from the Danish Civil Registration Register, the Cause of Death Register, the National Patient Register, the Diabetes Register and the Cancer Register. The effect of the intervention will be examined using Cox regression with intention-to-treat analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 30, 40, 50 or 60 years
  • living in one of the pre-specified municipalities of Copenhagen

Exclusion criteria

  • none

Treatment and study plan

General health checks

Other

The intervention group is invited to up to three general health checks over a 10-year period

Primary outcomes

  1. cardiovascular disease

    Time frame: 30 years of follow-up

  2. all-cause mortality

    Time frame: 30 years of follow-up

Secondary outcomes

  1. cancer

    Time frame: 30 years of follow-up

  2. Diabetes

    Time frame: 30 years of follow-up

  3. COPD

    Time frame: 30 years of follow-up

  4. Tobacco-related diseases

    Time frame: 30 years of follow-up

  5. Dementia

    Time frame: 30 years of follow-up

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Important dates

Study start
1982
Primary completion
1984
Study completion
2014
First posted
Mar 25, 2016
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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