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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Other: General health checks

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 17845
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup
    • Copenhagen, Glostrup, Denmark, DK-2600
      • Research Centre for Prevention and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group; Invitation to up to three general health checks over a 10-year period	Other: General health checks; The intervention group is invited to up to three general health checks over a 10-year period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cardiovascular disease	30 years of follow-up
all-cause mortality	30 years of follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
cancer	30 years of follow-up
Diabetes	30 years of follow-up
COPD	30 years of follow-up
Tobacco-related diseases	30 years of follow-up
Dementia	30 years of follow-up

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Allan Linneberg, Research Centre for Prevention and Health

Study record dates

Study Major Dates

• Study Start: January 1, 1982
• Primary Completion (Actual): December 1, 1984
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Estimate): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Monica Intervention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared upon request and approval from the Ethics Committee.