The IBD&me Randomized Controlled Trial
追踪信息 | |||
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首次提交日期 ICMJE | September 26, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 15, 2018 | ||
预计主要完成日期 | April 15, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Patient perception of shared decision-making[ Time Frame: one day after the clinic visit ] To assess the impact of the IBD&me decision aid on patient perceptions of shared decision-making, compared to a standardized education arm. Patient perception of shared decision-making, as measured by the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | The IBD&me Randomized Controlled Trial | ||
正式标题 ICMJE | Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial | ||
简要概况 | Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction. The principal objective of this study is to assess the impact of an online decision aid called IBD&me on patient perceptions of shared-decision making as compared to a standardized education arm. |
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详细说明 | Context: Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction. Objective: The principal objective of this study is to assess the impact of an online decision aid called IBD&me on patient perceptions of shared-decision making as compared to a standardized education arm. Hypothesis: IBD&me, through optimizing shared-decision making (SDM) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an SDM tool. Design: Pragmatic multicenter randomized controlled trial in IBD outpatient care 1. Intervention: IBD&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace 2. Control arm: Standardized, high-quality educational material from the Crohn's & Colitis Foundation | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Parallel Assignment 盲法: Interventional 盲法描述:Given the study design and intervention, it is not possible to ensure the blinding of patients and physicians. However, we will attempt to address the limitations resulting from a lack of blinding: Patients and the physicians will be informed of the study protocol, but will not be provided accurate information about the specific primary outcome (i.e. comparison between IBD&me and the Crohn's & Colitis Foundation of America (CCFA) resource). The informed consent document will keep participants blind to the study goals. Physicians will be kept blinded of the patient's assignment group until the clinic visit. Data will be collected by an independent researcher. Study investigators and the data analyst will remain blinded until all follow-up data is obtained and the primary analysis is finalized. 主要目的: Health Services Research |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
152 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 15, 2019 | ||
预计主要完成日期 | April 15, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 18 years of age or older - Have ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or inflammatory bowel disease unclassified (IBD-U) - Have experienced IBD related symptoms in the 30 days before screening - Considering discussing biologic therapies for controlling his or her IBD at the next clinic visit - Have an IBD-related visit scheduled at least 10 days and no later than 3 months following screening Exclusion Criteria: - Does not speak English - Does not have access to the Internet | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Brennan Spiegel,Cedars-Sinai Medical Center | ||
研究赞助商 ICMJE | Cedars-Sinai Medical Center | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Cedars-Sinai Medical Center | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |