Validation Study of Simplified Chinese Version of LOTCA Scale in the Assessment of Cognitive Impairment in Patients with Traumatic Brain Injury

Официальное название

A Confirmatory Study of the Simplified Chinese Version of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) Battery (2nd Edition) to Assess Cognitive Impairment in Patients with Traumatic Brain Injury

Обзор

In this study, 300 patients aged ≥18 years old with traumatic brain injury (case group) and hospitalized patients without central nervous system disease or their family members and accompanying staff (control group) were selected as the study objects. At baseline, participants completed the Mini-mental State Examination (MMSE), the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery, the Glasgow Coma Scale (GCS), and the Alzheimer's Disease Rating Scale Cognitive Subscale (ADAS-Cog11). The evaluation process of the first LOTCA test was videotaped by a person. 2 weeks after the evaluation, the same two scale raters watched the video and rated it independently again. After 3 months, the subjects completed MMSE, LOTCA battery, GCS, ADAS-Cog11 assessment again.

Вмешательства

• Другое Observation
  The study was observational and did not involve any intervention.

Первичные конечные точки

• Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery [Срок оценки: At baseline]
• Retest Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery [Срок оценки: 2 weeks Later]
• Internal Consistency Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery [Срок оценки: At baseline]
• Content Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery [Срок оценки: At baseline]
• Construct Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery [Срок оценки: At baseline]
• Discriminative Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery [Срок оценки: At baseline]
• The change of Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery score from baseline values [Срок оценки: 3 months later]
• The change of Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 score from baseline values [Срок оценки: 3 months later]
• Correlation between LOTCA score change from baseline and ADAS-Cog11 score change from baseline [Срок оценки: 3 months later]
• The area under ROC curve and the sensitivity, specificity and Jorden index under optimal threshold of LOTCA score change from baseline value [Срок оценки: 3 months later]

Критерии участия

Критерии включения

\- Case group: Patients with traumatic brain injury

Критерии включения

• Age> = 18 years old, male or female;
• patients with traumatic brain injury;
• The Mini-Mental State Examination (MMSE) score was lower than normal, and the cut-off value for diagnosis was determined according to different education levels: illiteracy (uneducated) <=19 points, primary school level <=22 points, junior high school level and above < = 26 points;
• Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.

Control group: family members or accompanying persons of patients in the same period

Критерии включения

• Age> = 18 years old, male or female;
• recent emotional stability;
• Mini-Mental State Examination (MMSE) score was normal;
• Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.

Критерии исключения

\- Case group: Patients with traumatic brain injury

Критерии исключения

• The study subject is in a lethargic state, coma, or persistent vegetative state;
• the disease progresses rapidly or is accompanied by serious complications;
• The subject has severe language dysfunction or/or bilateral upper limb motor function loss;
• the study subject has severe visual and/or hearing impairment;
• The subject has a severe mental disorder, physical weakness or other conditions (such as intolerance to the test or uncooperation, etc.);
• Those who have a history of drug abuse within 6 months before screening or those who have used drugs within 3 months before screening;
• Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons.

Control group: family members or accompanying persons of patients in the same period

Критерии исключения

• History of congenital or acquired central nervous system disease (including history of traumatic brain injury, cerebrovascular accident, etc.);
• Those who have a history of drug abuse within 6 months before screening or who have used drugs within 3 months before screening;
• Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 4 центра

• The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University — Huaian
• Suzhou Jiulong Hospital — Сучжоу
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou
• Northern Jiangsu People's Hospital — Yangzhou

Идентификаторы

NCT: NCT06850584 · LOTCA-YZ-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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