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临床试验/NCT01979107
NCT01979107已完成不适用

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

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 1,104 人开始时间: 2014年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,104
试验地点
2
主要终点
Change from baseline in smoking status at 12 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in smoking status at 12 months

时间窗: 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

时间窗: 12 months

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.

次要结局

  • Change from baseline in perceived stress level at 12 months(12 months)
  • Change from baseline in alcohol consumption at 12 months(12 months)
  • Change from baseline in physical activity level at 12 months(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Kamstrup-Larsen

Ph.D. Student

University of Southern Denmark

研究点 (2)

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