Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education

Not Applicable

Completed

• Conditions: Health Behavior; Chronic Disease; Smoking
• Interventions: Behavioral: Proactive action by the general practitioner

• Registration Number: NCT01979107
• Lead Sponsor: University of Southern Denmark

Brief Summary

In this randomized controlled study it is investigated if a proactive action by the general practitioner offering individuals without formal education a preventive health check will lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease, cardiovascular diseases, and diabetes among participants in the intervention group compared to the control group. Furthermore it will be investigated if the proactive action by the general practitioner will be associated with a higher smoking cessation rate at 12 month follow-up.

Detailed Description

The study will be conducted at Vesterbro and Amager in Copenhagen, Denmark, and general practitioners with a medical practice in this area will be invited to enter the study. From the patient lists of the participating general practitioners all persons aged 45-64 years will be identified and baseline questionnaires will be mailed to these persons.

The questionnaire information will be entered electronically into the general practitioners electronic chart system using the Danish Quality Unit of General Practice (DAK-E) system. Thus, the questionnaire information will provide the general practitioners with information in the electronic form on health behavior, symptoms and socioeconomic information on all his patients in this age group that would not normally have access to in a systematic way.

Persons who answer the baseline questionnaire and who do not have any formal education will randomly be divided into two groups - one intervention group and one control group.

All persons allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. The health check at the general practitioner includes measurement of weight, height, hip and waist circumference, blood pressure, lung function, blood sugar, total cholesterol, and thyroidal status.

Participants with abnormal screens at the health check will, depending of the severity, either receive the offer of the referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. For individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check.

Persons allocated to the control group will receive a baseline questionnaire and other than that follow normal procedure in general practice.

At 12 month follow-up questionnaires will be send out to all participants at the intervention group as well as the control group.

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Study Start: 2014-04-22
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1104

Inclusion Criteria

• Participants must be 45-64 years old with no formal education beyond secondary school
• Participants must live in Copenhagen
• Participants' general practitioner must be participating in the study

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive action by the general practitioner	Proactive action by the general practitioner	Proactive action by the general practitioner inviting to preventive health check.

Primary Outcome Measures

Name	Time	Method
Change from baseline in smoking status at 12 months	12 months	Change in the participants' smoking status from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.
Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes	12 months	Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes at 12 months. Number of chronic diseases are obtained from the general practitioner and from a number of administrative registers.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in perceived stress level at 12 months	12 months	Change in the participants' perceived stress level measured with perceived stress scale (10 items). Measured with self-reported questionnaires at baseline and at 12 months.
Change from baseline in alcohol consumption at 12 months	12 months	Change in the participants' alcohol consumption from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.
Change from baseline in physical activity level at 12 months	12 months	Change in the participants' physical activity level from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.

Trial Locations

Locations (1)

National Institute of Public Health - University of Southern Denmark; 🇩🇰 Copenhagen, Copenhagen K, Denmark