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临床试验/NCT00164658
NCT00164658已完成1 期

Evaluating Tools for Health Promotion and Disease Prevention

Centers for Disease Control and Prevention6 个研究点 分布在 1 个国家目标入组 8,400 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
8,400
试验地点
6
主要终点
Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation

研究概览

简要总结

The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.

详细描述

The purpose of this study is to evaluate the clinical utility of a new family history tool, Family Healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. An additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice).

The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. The practices will be randomized into two groups. Patients in practices randomized to Group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. After 6 months Group 2 patients will complete the post-test and the family history tool. The pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).

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
Single

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • member of participating primary care practice network
  • able to provide informed consent
  • able to complete data assessment tools in English

排除标准

  • diagnosis of CHD, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer
  • currently pregnant
  • evidence of cognitive impairment

结局指标

主要结局

Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation

次要结局

  • Primary care physicians' provision of preventive services in response to family medical history.

研究者

研究点 (6)

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