Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Primary Purpose
Smoking, Health Behavior, Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Proactive action by the general practitioner
Sponsored by
About this trial
This is an interventional prevention trial for Smoking focused on measuring Health behavior, Chronic disease, Proactive action, General practitioner, Preventive health check, Social inequality in health, Randomised controlled trial
Eligibility Criteria
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:
-
Sites / Locations
- National Institute of Public Health - University of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Proactive action by the general practitioner
Control group
Arm Description
Proactive action by the general practitioner inviting to preventive health check.
The participants will be treated as usual by the general practitioner.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01979107
First Posted
October 25, 2013
Last Updated
January 17, 2019
Sponsor
University of Southern Denmark
Collaborators
Danish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT01979107
Brief Title
Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Official Title
Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 22, 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Danish Cancer Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Health Behavior, Chronic Disease
Keywords
Health behavior, Chronic disease, Proactive action, General practitioner, Preventive health check, Social inequality in health, Randomised controlled trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proactive action by the general practitioner
Arm Type
Experimental
Arm Description
Proactive action by the general practitioner inviting to preventive health check.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants will be treated as usual by the general practitioner.
Intervention Type
Behavioral
Intervention Name(s)
Proactive action by the general practitioner
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in smoking status at 12 months
Description
Change in the participants' smoking status from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.
Time Frame
12 months
Title
Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in alcohol consumption at 12 months
Description
Change in the participants' alcohol consumption from baseline to 12 month follow-up. Measured with self-reported questionnaires at baseline and at 12 months.
Time Frame
12 months
Title
Change from baseline in physical activity level at 12 months
Description
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.
Time Frame
12 months
Title
Change from baseline in perceived stress level at 12 months
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Grønbæk, MD, PhD.
Organizational Affiliation
Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Public Health - University of Southern Denmark
City
Copenhagen
State/Province
Copenhagen K
ZIP/Postal Code
1353
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31604416
Citation
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.
Results Reference
derived
PubMed Identifier
31537563
Citation
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.
Results Reference
derived
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Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
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