UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049802 |
|---|---|
| Receipt number | R000054504 |
| Scientific Title | Development of The Awareness Questionnaire(AQ) , self-awareness assessment method after acquired brain injury in Japan: Using Structural Equation and Item Response Models |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/12/16 00:40:40 |
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Basic information
Public title
Development of The Awareness Questionnaire(AQ) , self-awareness assessment method after acquired brain injury in Japan: Using Structural Equation and Item Response Models
Acronym
Development of AQ in Japan: Using Structural Equation and Item Response Models
Scientific Title
Development of The Awareness Questionnaire(AQ) , self-awareness assessment method after acquired brain injury in Japan: Using Structural Equation and Item Response Models
Scientific Title:Acronym
Development of AQ in Japan: Using Structural Equation and Item Response Models
Region
| Japan |
Condition
Condition
stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to extend the master's research and to investigate in detail the Japanese version of the AQ scale according to COSMIN.
Basic objectives2
Others
Basic objectives -Others
By developing an assessment of self-awareness, it is possible to understand the symptoms and behavioral characteristics of patients from the perspective of self-awareness. As a result, it can be expected to consider appropriate interventions according to the degree of Self-awareness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of The Awareness Questionnaire
Key secondary outcomes
Glasgow Coma Scale, Mini Mental State Examination, Functional Independence Measure, Japanese version of Self Regulation Skills Interview, Trail Making Test, Wisconsin Card Sorting Test, digit span, Rey Osterrieth Complex Figure Test
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with stroke, patients who have given written consent to participate in the study, and patients who have the language ability to be assessed in this study.
Key exclusion criteria
Patients who do not meet selection criteria
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Chinaru |
| Middle name | |
| Last name | Kajimoto |
Organization
Itami Kousei Neurosurgery Hospital
Division name
Rehabilitation Department
Zip code
664-0028
Address
1-300-1, Nishino, Itami-shi, Hyogo, Japan
TEL
072-781-6600
chinaruxfukuyama@gmail.com
Public contact
Name of contact person
| 1st name | Chinaru |
| Middle name | |
| Last name | Kajimoto |
Organization
Itami Kousei Neurosurgery Hospital
Division name
Rehabilitation Department
Zip code
664-0028
Address
1-300-1, Nishino, Itami-shi, Hyogo, Japan
TEL
072-781-6600
Homepage URL
chinaruxfukuyama@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Graduate School of Rehabilitation Science
Address
3-7-30, Habikino, Habikino, Osaka, Japan
Tel
072-950-2111
sf22285z@st.omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
伊丹恒生脳神経外科病院（兵庫県），他
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient information to be extracted included age, gender, disease name, hemisphere of injury, injury site, dominant hand, educational history, number of days since onset, GCS, MMSE, and ADL assessment FIM. The efficacy outcome is the SA assessment: AQ Japanese version, Japanese version of SRSI, MMSE, TMT, WCST, digit span, and Rey's complex graphic test.
Covariance structure analysis was conducted for structural validity. First, maximum likelihood and promax rotation methods are used as exploratory factor analysis. Then, confirmatory factor analysis is conducted to verify the goodness of fit of the factor structure model of the scale. CFI, TLI, and RMSEA are used as the model fit indices. Next, in order to capture the item characteristics of the scale, we use item response theory to calculate a characteristic curve based on a step response model using discrimination and difficulty, test response function and test information function. The item population is estimated by using the marginal maximum likelihood estimation method based on the EM algorithm, and the goodness-of-fit is verified in the same way as in confirmatory factor analysis.
In addition, Cronbach's alpha coefficient is calculated and used to examine internal consistency for reliability. To examine the validity of the Japanese version of the AQ, Spearman's rank correlation coefficient and Pearson's correlation coefficient are used to examine the relationship between the Japanese version of the AQ and each indicator, with and without normalization. The effects of ceiling and floor effects are examined. R, JMP, Jamovi, and Amos were used for the above statistical analyses, with a significance level of 5% for each statistic.
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054504
