Epidemiological Studies of Health Effects of General Examinations

NCT02719678 | Completed DMC

• 1 other identifier: Monica Intervention
• Study Type: interventional
• Target: 17,845
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• cardiovascular disease

  30 years of follow-up

• all-cause mortality

  30 years of follow-up

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Invitation to up to three general health checks over a 10-year period

Other: General health checks

Control group

NO INTERVENTION

Control group

Interventions

General health checks OTHER

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

Intervention group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Research Centre for Prevention and Health

Copenhagen, Glostrup, DK-2600, Denmark

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Allan Linneberg

  Research Centre for Prevention and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: January 1, 1982
• Primary Completion: December 1, 1984
• Study Completion: September 1, 2014
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)