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临床试验/NCT06401811
NCT06401811招募中不适用

Reliability, Validity, and Responsiveness of the Turkish Version of Eating Assessment Tool-10 for Patients With Primer Sjögren's Syndrome

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Turkish Eating Assessment Tool

研究概览

简要总结

Evaluations will be made by researchers following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management.

In addition, for the reliability of the Turkish Eating Assessment Tool-10, the Turkish Eating Assessment Tool-10 will be repeated on patients at least one-fifth of the number of individuals included, after one week.

For the sensitivity of the scale, an exercise that is routinely applied in the Rheumatological Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation will be invited and after 3 months, the same evaluations as applied in the first measurement will be made again on individuals at least one-fifth of the number of individuals included.

研究设计

研究类型
Observational
观察模型
Other
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
否

入选标准

  • •Patients diagnosed with Primary Sjögren's Syndrome
  • •18 years or older

排除标准

  • •Patients with Secondary Sjögren's Syndrome,
  • •Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
  • •Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

结局指标

主要结局

Turkish Eating Assessment Tool

时间窗: Baseline-first week-third month

Turkish Eating Assessment Tool-10 is a survey consisting of 10 questions with a Likert scale between 0 and 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by finding the sum of the answers given by individuals to each question. A score of 3 or more in the survey is considered abnormal. A score of 16 or above is considered a suspicion of aspiration. Turkish validity and reliability were tested by authors in 2016.

次要结局

  • Yale Swallow Protocol(Baseline-third month)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazli Elif Nacar

Lecturer

Kahramanmaras Sutcu Imam University

研究点 (1)

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