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临床试验/NCT03696134
NCT03696134招募中不适用

Investigating Musculoskeletal Health and Wellbeing: A Cohort Study

University of Nottingham1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2018年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals

时间窗: 5 years

Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight).

Presence and prevalence of disability

时间窗: 5 years

Disability will be determined using the five Fried Criteria modified for questionnaire delivery.

Presence and prevalence of pain

时间窗: 5 years

Pain distribution will be recorded in a pain manikin.

次要结局

  • 1. Classification of phenotypic subgroups(5 years)
  • 2. Classification of comorbid conditions(5 years)
  • 3. Medication usage(5 years)
  • 4. Identification of potential research participants(5 years)
  • Prevalence of Comorbid conditions(5 years)
  • Classification of Rheumatic Comorbid conditions(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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