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A Menopause Interactive Decision Aid System

2006年6月26日 更新者:Rhode Island Hospital
The purpose of this study is to develop and test a web-based system intended to help women going through menopause make more informed choices regarding menopause treatments. The system will do this by giving women personalized feedback on the risks and benefits of these treatments.

研究概览

地位

未知

条件

详细说明

Most women are not satisfied with the counseling they receive about menopause. To improve menopause counseling and help menopausal women more actively participate in the decision making process, we have developed a novel prototype web-based decision aid. Our immediate goal is to develop this prototype technology into a comprehensive Menopause Interactive Decision Aid System (MIDAS) that provides personalized feedback about menopausal symptoms, risks for common conditions, and the effects of different treatment options on the short- and long-term consequences of menopause.

Our main study hypotheses are that MIDAS can: 1) lead to better decisions and improve the quality of menopausal counseling; 2) improve compliance with a chosen menopausal plan; and 3) reduce medical errors associated with the use of menopausal therapies.

We propose a 2-phase study conducted over 3 years. Phase I will transform the prototype application into a comprehensive MIDAS, completing its content and risk assessment instruments, and exploring its optimal design. This will be accomplished through conduct of focus groups and usability tests. Phase II will formally evaluate the impact of MIDAS in a randomized, controlled, multi-center clinical trial involving diverse patient populations and clinician settings. We will measure the impact of MIDAS on the decision-making process as well as its effect on providers and outcome measures related to menopause, including compliance, quality of life, and medical errors related to menopausal therapy. Analyses will evaluate the extent to which the impact of MIDAS on these outcomes varies according to patient, practice, and physician characteristics.

研究类型

介入性

注册

296

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02120
        • Brigham and Women's Hospital
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • English-speaking
  • Between 45 and 65 years of age
  • Patient at participating clinics
  • Experience menopausal symptoms or being 6 months or more past last menstrual period
  • Have an upcoming appointment for menopausal counseling or annual physical exam (only applicable for clinical trial participants)

Exclusion Criteria:

  • Inability to give informed consent
  • Dementia
  • Age over 65 years
  • Pre-existing terminal illness that limits life expectancy to less than 2 years
  • History of breast cancer or cardiovascular disease

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:教育/咨询/培训
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
沮丧
焦虑
与健康相关的生活质量
决策冲突
Knowledge of the benefits, risks and side effects of menopausal treatments
Risk perception for breast cancer, CHD, and hip fracture
Patient-physician communication
Satisfaction with decision
Quality of menopausal counseling
Adherence to medication and lifestyle changes
Menopause-specific quality of life

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nananda F Col, MD, MPH, MPP、Rhode Island Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年7月1日

研究注册日期

首次提交

2006年6月26日

首先提交符合 QC 标准的

2006年6月26日

首次发布 (估计)

2006年6月27日

研究记录更新

最后更新发布 (估计)

2006年6月27日

上次提交的符合 QC 标准的更新

2006年6月26日

最后验证

2006年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01HS013329-02 (美国 AHRQ 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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