UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041051 |
|---|---|
| Receipt number | R000046877 |
| Scientific Title | Inter-rater reliability of public ADL scale in Japan, "bedriddennessrank" and "cognitive function score", using kappa coefficients; prospective study of 273 patients admitted to an acute care hospital |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2021/07/16 09:49:46 |
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Basic information
Public title
Inter-rater reliability of public ADL scale in Japan, "bedriddennessrank" and "cognitive function score", using kappa coefficients; prospective study of 273 patients admitted to an acute care hospital
Acronym
Kappa coefficients of "bedriddennessrank" and "cognitive function score"
Scientific Title
Inter-rater reliability of public ADL scale in Japan, "bedriddennessrank" and "cognitive function score", using kappa coefficients; prospective study of 273 patients admitted to an acute care hospital
Scientific Title:Acronym
Kappa coefficients of "bedriddennessrank" and "cognitive function score"
Region
| Japan |
Condition
Condition
inpatients
Classification by specialty
| Medicine in general | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the inter-rater reliability of public ADL scale in Japan "Bedriddenness rank" and "Cognitive function score".
Basic objectives2
Others
Basic objectives -Others
Evaluation of indicator
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
kappa coefficient
Key secondary outcomes
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All inpatients over the age of 75
Key exclusion criteria
Did not consent to this study
Hospitalization for less than 24 hours
Bad general condition
Any other reason that makes the investigation difficult
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga university hospital
Division name
General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
81-952-34-3238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga university hospital
Division name
General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
81-952-34-3238
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga university hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Yuai-kai Foundation and Oda Hospital
Address
4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel
81-954-63-3275
renkei@yuai-hc.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02108-x
Publication of results
Published
Result
URL related to results and publications
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02108-x
Number of participants that the trial has enrolled
271
Results
The concordance rate between the two BR assessments was 68.6%, with a kappa coefficient of 0.61, Cronbach's alpha of 0.91, and an intraclass correlation coefficient of 0.83. BR was negatively correlated with the Barthel Index and Katz Index.
The concordance rate between the two CFS assessments was 70.1%, with a kappa coefficient of 0.62, Cronbach's alpha of 0.87, and an intraclass correlation coefficient 0.78. CFS
was negatively correlated with the Barthel Index and Katz Index.
Results date posted
| 2021 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
New inpatients aged >=75 years were enrolled .
Participant flow
During the study period, 3222 inpatients aged 75 years or older were admitted, 2906 of whom were excluded according to the exclusion criteria. After excluding patients with missing data, 271 patients were eligible to be enrolled.
Adverse events
None.
Outcome measures
BR and CFS were assessed once by an attending nurse, and then by a social worker/medical clerk. We evaluated interrater reliability between different professions by calculating the concordance rate, kappa coefficient, Cronbach's alpha, and intraclass correlation coefficient. We also estimated the relationship of the Barthel Index and Katz Index with the BR and CFS using Spearman's correlation coefficients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The level of independence of daily living (bed-riddenness and cognition) on admission was assessed twice, and the kappa coefficient was calculated. The first assessment was performed by a nurse and the second assessment was performed by a social worker or medical clerk. Age (years), gender (male and female), emergency transport (yes or no), referral from another hospital (yes or no), length of stay (days), and Departments admitted (general medicine, general surgery, cardiology, dermatology, otolaryngology, neurosurgery), MHWL daily Information on the level of independence of living (bed-riddenness and cognition) was collected from the medical records.
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2021 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046877
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/03/01 | 20210301N UMIN登録データ271.xlsx |
