- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01979107
Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Copenhagen K
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Copenhagen, Copenhagen K, Danemark, 1353
- National Institute of Public Health - University of Southern Denmark
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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:
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Control group
The participants will be treated as usual by the general practitioner.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in smoking status at 12 months
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in alcohol consumption at 12 months
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Morten Grønbæk, MD, PhD., Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 61110-2095
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