UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045078
Receipt number R000051479
Scientific Title Correlation of bedriddenness ranks with Barthel Index and Katz Index, and cognitive function scores with MMSE and ABC-DS
Date of disclosure of the study information 2021/08/06
Last modified on 2023/04/16 17:02:54

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Basic information

Public title

Correlation of bedriddenness ranks and cognitive function scores with other scales of ADL and dementia

Acronym

Correlation of bedriddenness ranks and cognitive function scores with other scales

Scientific Title

Correlation of bedriddenness ranks with Barthel Index and Katz Index, and cognitive function scores with MMSE and ABC-DS

Scientific Title:Acronym

Correlation of bedriddenness ranks and cognitive function scores with other objective scales of ADL and dementia

Region

Japan


Condition

Condition

Inpatients

Classification by specialty

Medicine in general Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the criterion-related validity of the official ADL scales in Japan, bedriddenness ranks and cognitive function scores, and other scales.

Basic objectives2

Others

Basic objectives -Others

Spearman's correlation coefficients between bedriddenness ranks and Katz index or Barthel index, and cognition and MMSE or ABC-DS Spearman's rank correlation coefficients

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Spearman's rank correlation 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients aged 20 years and older admitted to Yuai-kai Foundation and Oda Hospital between October 1, 2018, and September 30, 2019

Key exclusion criteria

Input error
Missing data of bedriddenness ranks and cognitive function scores
Patients who did not give consent to the research

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Tago

Organization

Saga University Hospital

Division name

Department of General Medicine

Zip code

8498501

Address

5-1-1 Nabeshima, Saga

TEL

81-952-34-3238

Email

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

Department of General Medicine

Zip code

8498501

Address

5-1-1 Nabeshima, Saga

TEL

81-952-34-3238

Homepage URL


Email

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

Yuai-Kai Foundation and Oda Hospital

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

Email

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

2021 Year 08 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1371/journal.pone.0277540

Number of participants that the trial has enrolled

3148

Results

We enrolled 3,003 patients. Spearman's rank correlation coefficients between Bedriddenness Rank and the Barthel Index and Katz Index were -0.891 (p < 0.001) and -0.877 (p < 0.001), respectively. Spearman's rank correlation coefficients between Cognitive Function Score and MMSE and ABC-DS were -0.546 (p < 0.001) and -0.862 (p < 0.001), respectively.

Results date posted

2023 Year 04 Month 16 Day

Results Delayed

Delay expected

Results Delay Reason

We need additional time for data collection and writing the article.

Date of the first journal publication of results

2022 Year 11 Month 10 Day

Baseline Characteristics

Although 3,003 inpatients were enrolled, Bedriddenness Rank (BR) was not assessed in 32 patients, and Cognitive Function Score (CFS) was not assessed in 41 patients. As a result, BR was analyzed in 2,971 patients and CFS was analyzed in 2,962 patients. The median age of the overall population was 77 (IQR: 63-86) years, and 1,451 patients (48.3%) were male. The median length of hospital stay was 9 (IQR: 4-16) days. BR was normal in 1,664 patients (56%), and Barthel Index (BI) and Katz Index (KI) were assessed in 2,954 patients, with median values of 100 (IQR: 65-100) and 6 (IQR: 2-6), respectively. CFS was normal in 1,967 patients (65.5%), and the MMSE was conducted in 951 patients among the other 1,036 patients with abnormal CFS, and ABC-DS was performed in all patients regardless of the CFS results. The median values of MMSE and ABC-DS were 15 (IQR: 2-21) and 117 (IQR: 102-117), respectively.

Participant flow

A total of 3,148 inpatients were admitted during the study period. Among them, 109 were excluded because they were younger than 20 years old, and 36 were excluded because of protocol deviation or suspected input errors. Although the remaining 3,003 inpatients were enrolled, BR was not assessed in 32 patients, and CFS was not assessed in 41 patients. As a result, BR was analyzed in 2,971 patients and CFS was analyzed in 2,962 patients.

Adverse events

None

Outcome measures

Spearman's rank correlation coefficient

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 29 Day

Date of IRB

2018 Year 07 Month 02 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2019 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

All adult inpatients admitted between Oct. 1, 2018, and Sept. 30, 2019, were included in this single-center prospective observational study. The participants were assessed on admission for follows; bedriddenness ranks, cognition function scores, basic ADL (eating, transferring, personal care, toileting activities, bathing, walking, stair climbing, dressing, defecation, and urination), BI, KI, MMSE, and ABC-DS.


Management information

Registered date

2021 Year 08 Month 06 Day

Last modified on

2023 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051479


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/08/08 Data set UMIN000045078.xlsx