Massive Individualized N-of-1 Experiments (MINEs)
赞助:
University of California, Davis
合作者:
信息的提供 (责任方):
Richard L. Kravitz, MD, MSPH，University of California, Davis
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 2, 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 | February 1, 2019 | ||
| 预计主要完成日期 | May 30, 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 |
Stress[ Time Frame: 18 days ] How stressed are you feeling today? (single item Likert scale) Focus[ Time Frame: 18 days ] How focused are you feeling today? (single item Likert scale) Happiness[ Time Frame: 18 days ] How happy are you feeling today? (single item Likert scale) |
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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 | Massive Individualized N-of-1 Experiments (MINEs) | ||
| 正式标题 ICMJE | Massive Individualized N-of-1 Experiments Using HackYourHealth: A New Paradigm for Promoting Health and Well-Being | ||
| 简要概况 | The project will enroll up to 10,000 adult volunteers in individualized experiments (N-of-1 trials) designed to assess the individual-level effects of any of five interventions on three outcomes. The five interventions are: gratitude journaling, mindfulness meditation, random acts of kindness, physical activity, and laughter therapy. The three outcomes are stress, cognitive focus, and happiness. Each participant will engage in the selected activity in 3 day intervals, separated at random by 3 day intervals of usual activity, for a total of six 3-day periods (18 days). |
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| 详细说明 | N-of-1 trials (single patient crossover experiments) are a uniquely powerful technique for estimating treatment effects in the individual. N-of-1 trials have been offered to hundreds or perhaps thousands of patients worldwide, but never at scale. HackYourHealth is a tool that supports the conduct of simple N-of-1 self-experiments to test if healthy activities that work in general (i.e., mindfulness meditation, physical activity, gratitude journaling, random acts of kindness, and laughter therapy), improve psychological well-being (stress, focus, happiness) in specific individuals. The tool supplies the experimental design, facilitates data analysis, and channels feedback to participants. The tool is flexible enough to support Massive Individualized N-of-1 Experiments (MINEs) at scale. Working with WNYC Radio in New York City, we will recruit and run 18-day N-of-1 trials up to 10,000 individuals. The purpose of this study is to conduct a formative evaluation of HackYourHealth in terms of its perceived usefulness and to explore heterogeneity in intervention response across the sample. We anticipate that the results will: 1) identify useful behavioral interventions for individual participants; 2) help to estimate generalizable treatment effects for the interventions of interest; 3) assess heterogeneity of treatment effects across subgroups; and 4) elucidate the user experience with N-of-1 trials. When complete, the study will support additional proposals designed to assess the utility of MINEs as applied to additional conditions and treatments. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Sequential Assignment 干预模型描述: Each participant will enroll in a personalized ("N-of-1") crossover trial. 盲法: Interventional 盲法描述:The analysis will proceed automatically without knowledge of which 3-day treatment periods were associated with one of the five interventions and which were associated with the subject's usual activities. 主要目的: Treatment |
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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 |
500 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2019 | ||
| 预计主要完成日期 | May 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Age 18 or over - Living anywhere in the United States - Using a smartphone - Having regular access to internet on their phone - Able to read and write in English Exclusion Criteria: There are no exclusion criteria, except that patients with pre-existing cardiovascular disease will be cautioned not to engage in new types of physical activity without consulting a physician. | ||
| 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 | Richard L. Kravitz, MD, MSPH，University of California, Davis | ||
| 研究赞助商 ICMJE | University of California, Davis | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of California, Davis | ||
| 验证日期 | October 2018 | ||
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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 |
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