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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking, Health Behavior, Chronic Disease

Intervention / Treatment
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* Behavioral: Proactive action by the general practitioner


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proactive action by the general practitioner<br>Proactive action by the general practitioner inviting to preventive health check. | Behavioral: Proactive action by the general practitioner<br>* 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.<br>|
| No Intervention: Control group<br>The participants will be treated as usual by the general practitioner. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health behavior, Chronic disease, Proactive action, General practitioner, Preventive health check, Social inequality in health, Randomised controlled trial