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临床试验/NCT03116204
NCT03116204已完成不适用

Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score

Hospices Civils de Lyon9 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2018年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
9
主要终点
Assessment of the validity of SAS

研究概览

简要总结

A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...

The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).

We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

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

入选标准

  • Men and women aged 2 years old
  • Hospitalized in the participating department for at least 4 days
  • For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery

排除标准

  • Non-recipient of French Social Security

结局指标

主要结局

Assessment of the validity of SAS

时间窗: Day 0

The construct validity will be determined by an exploratory factor analysis and confirmed on an independent sample. Criterion validity will be studied by comparison of scores obtained from SAS to scores obtained from references scale (FIM, WeeFIM, ADL, IADL, BREF, BREV, MMSE and items of WISC IV).

Assessment of the reliability of SAS.

时间窗: Day 7

For the inter rater reliability study, patients will be rated on the same day by two groups of therapists. For the test-retest reliability study, patients will be rated twice during their hospitalization, within a time frame sufficiently close so that their dependency should not change.

次要结局

  • Study of SAS responsiveness(6 months)
  • Study of invariance of SAS: invariance of the classification between age and sex classes.(day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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