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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979107
• Other study ID #: 61110-2095
• Status: Completed
• Phase: N/A
• Start date: April 22, 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1104
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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:

Related Conditions & MeSH terms

• Chronic Disease
• Health Behavior
• Smoking

Intervention

Behavioral:
• Proactive action by the general practitioner
Individuals allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. Three days before the appointment participants will be reminded by phone about the appointment. At the health check a follow-up consultation will be scheduled. At the follow-up consultation the results of the health check will be reviewed. All participants with abnormal screens at the health check will, depending of the severity, either receive the offer of a referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. This will follow the usual medical standards in general practice. 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 with a follow-up consultation for review of the results.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health - University of Southern Denmark	Copenhagen	Copenhagen K

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in smoking status at 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.	12 months
Primary	Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes	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.	12 months
Secondary	Change from baseline in alcohol consumption at 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.	12 months
Secondary	Change from baseline in physical activity level at 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.	12 months
Secondary	Change from baseline in perceived stress level at 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.	12 months