Epidemiological Studies of Health Effects of General Examinations

Cardiovascular Disease Clinical Trial

Official title:

Epidemiological Studies of Health Effects of General Examinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719678
• Other study ID #: Monica Intervention
• Status: Completed
• Phase: N/A
• First received: March 21, 2016
• Last updated: March 24, 2016
• Start date: January 1982
• Est. completion date: September 2014

Study information

• Verified date: March 2016
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17845
• Est. completion date: September 2014
• Est. primary completion date: December 1984
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• age 30, 40, 50 or 60 years

• living in one of the pre-specified municipalities of Copenhagen

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Research Centre for Prevention and Health	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular disease		30 years of follow-up	No
Primary	all-cause mortality		30 years of follow-up	No
Secondary	cancer		30 years of follow-up	No
Secondary	Diabetes		30 years of follow-up	No
Secondary	COPD		30 years of follow-up	No
Secondary	Tobacco-related diseases		30 years of follow-up	No
Secondary	Dementia		30 years of follow-up	No