Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
OTHERObservation
The study was observational and did not involve any intervention.
Sponsors
Nanjing Broad Biopharmaceutical Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Case group: Patients with traumatic brain injury Inclusion Criteria: 1. Age\> = 18 years old, male or female; 2. patients with traumatic brain injury; 3. 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; 4. 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 Inclusion Criteria: 1. Age\> = 18 years old, male or female; 2. recent emotional stability; 3. Mini-Mental State Examination (MMSE) score was normal; 4. Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.
Exclusion criteria
\- Case group: Patients with traumatic brain injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery | At baseline |
| Retest Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery | 2 weeks Later |
| Internal Consistency Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery | At baseline |
| Content Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery | At baseline |
| Construct Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery | At baseline |
| Discriminative Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery | At baseline |
| The change of Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery score from baseline values | 3 months later |
| The change of Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 score from baseline values | 3 months later |
| Correlation between LOTCA score change from baseline and ADAS-Cog11 score change from baseline | 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 | 3 months later |
Countries
China
Outcome results
None listed