Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Copenhagen K
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Copenhagen, Copenhagen K, Denemarken, 1353
- National Institute of Public Health - University of Southern Denmark
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Proactive action by the general practitioner
Proactive action by the general practitioner inviting to preventive health check.
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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. |
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Geen tussenkomst: Control group
The participants will be treated as usual by the general practitioner.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in smoking status at 12 months
Tijdsspanne: 12 months
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Change in the participants' smoking status from baseline to 12 month follow-up.
Measured with self-reported questionnaires at baseline and at 12 months.
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12 months
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Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes
Tijdsspanne: 12 months
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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.
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in alcohol consumption at 12 months
Tijdsspanne: 12 months
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Change in the participants' alcohol consumption from baseline to 12 month follow-up.
Measured with self-reported questionnaires at baseline and at 12 months.
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12 months
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Change from baseline in physical activity level at 12 months
Tijdsspanne: 12 months
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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.
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12 months
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Change from baseline in perceived stress level at 12 months
Tijdsspanne: 12 months
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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.
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12 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Morten Grønbæk, MD, PhD., Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 61110-2095
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