Investigating Musculoskeletal Health and Wellbeing
追踪信息 | |||
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首次提交日期 ICMJE | September 17, 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 | June 22, 2018 | ||
预计主要完成日期 | June 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 |
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals[ Time Frame: 5 years ] Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight). Presence and prevalence of pain[ Time Frame: 5 years ] Pain distribution will be recorded in a pain manikin. Presence and prevalence of disability[ Time Frame: 5 years ] Disability will be determined using the five Fried Criteria modified for questionnaire delivery. |
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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 | Investigating Musculoskeletal Health and Wellbeing | ||
正式标题 ICMJE | Investigating Musculoskeletal Health and Wellbeing: A Cohort Study | ||
简要概况 | Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations. Methods A prospective cohort of 10000 people aged > 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale). Discussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified. |
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详细说明 | |||
研究类型 ICMJE | Observational | ||
研究阶段 | |||
研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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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 | Recruiting | ||
预计入组 ICMJE |
10000 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | April 30, 2023 | ||
预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Ability to give informed consent. Aged 18 and over Frailty score of ≥ 0.12 on the eFI Have or are at risk of developing musculoskeletal frailty, pain or disability Exclusion Criteria: - Inadequate understanding of verbal explanations or written information in English; Special communication needs; Receiving dialysis; Receiving home oxygen; Terminal cancer; Unstable angina or heart failure; Serious mental illness; Dementia. | ||
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 | United Kingdom | ||
管理信息 | 数据检测委员会 | ||
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 | , | ||
研究赞助商 ICMJE | University of Nottingham | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
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 |