跳至主要内容
临床试验/NCT00164658
NCT00164658
已完成
1 期

Evaluating Tools for Health Promotion and Disease Prevention

Centers for Disease Control and Prevention3 个研究点 分布在 1 个国家目标入组 8,400 人2005年9月

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Coronary Heart Disease
发起方
Centers for Disease Control and Prevention
入组人数
8400
试验地点
3
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
状态
已完成
最后更新
16年前

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).

注册库
clinicaltrials.gov
开始日期
2005年9月
结束日期
2007年10月
最后更新
16年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

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.

研究点 (3)

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