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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Chronic Disease; Health Behavior
• Intervention / Treatment: Behavioral: Proactive action by the general practitioner

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 Type: Interventional
• Enrollment (Actual): 1104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen K
    • Copenhagen, Copenhagen K, Denmark, 1353
      • National Institute of Public Health - University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proactive action by the general practitioner; Proactive action by the general practitioner inviting to preventive health check.	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.
No Intervention: Control group; The participants will be treated as usual by the general practitioner.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Danish Cancer Society
• Investigators: Study Director: Morten Grønbæk, MD, PhD., Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark

Publications and helpful links

General Publications

• Kamstrup-Larsen N, Broholm-Jorgensen M, Dalton SO, Larsen LB, Thomsen JL, Tolstrup JS. Why do general practitioners not refer patients to behaviour-change programmes after preventive health checks? A mixed-method study. BMC Fam Pract. 2019 Oct 11;20(1):135. doi: 10.1186/s12875-019-1028-2.
• Kamstrup-Larsen N, Dalton SO, Gronbaek M, Broholm-Jorgensen M, Thomsen JL, Larsen LB, Johansen C, Tolstrup J. The effectiveness of general practice-based health checks on health behaviour and incidence on non-communicable diseases in individuals with low socioeconomic position: a randomised controlled trial in Denmark. BMJ Open. 2019 Sep 18;9(9):e029180. doi: 10.1136/bmjopen-2019-029180.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Chronic disease; General practitioner; Health behavior; Social inequality in health; Proactive action; Preventive health check
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 61110-2095