UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041022 |
|---|---|
| Receipt number | R000043953 |
| Scientific Title | A |
| Date of disclosure of the study information | 2020/07/07 |
| Last modified on | 2020/07/07 11:04:44 |
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Basic information
Public title
A
Acronym
A
Scientific Title
A
Scientific Title:Acronym
A
Region
| Japan |
Condition
Condition
Inpatients in neurology and their families
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a survey of patients, their families and health care professionals about the hospital rooms at Nara Medical University. The primary purpose of the study is to evaluate the impact of the comfort environment on patients' cognitive function and light levels, with the secondary purpose of be (a person)
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of a survey of patients, their families, and the health care professionals who worked with them on the ward
Key secondary outcomes
The amount of light the patient himself was exposed to
Light intensity of the hospital bed
Differences in cognitive function (at admission and discharge) and sleep efficiency in different bed environments
Relationship between sleep indices and delirium during hospitalization
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
During the period covered. Ward C, Room 525, 5th floor, Ward 4 (a room with a simulated window) (Ref. 2) Ward C, Room 525, 5th floor, Ward 2 (the room with a pseudo-window in the same corridor as the room with a pseudo-window) Ward C, Room 525, 5th floor, Wards 1 and 3 (window side of the same room as the room with the artificial window) Patients scheduled to be admitted to Patients over 20 years old Patients with a score of 20 or more on the Mini Mental State Examination (MMSE) at the time of admission Patients with a level of independence of daily living (bed-riddenness) J, A, and B for disabled elderly people Patients who can understand Japanese patient and family Family members of eligible patients (any one of them within the third degree of kinship) Those that can understand Japanese. You have understood and agreed to the purpose of this study. The patient's physician and primary nurse You have understood and agreed to the purpose of this study. (He is a health care worker working at the hospital, so exclusion on cognitive function or language is unlikely.)
Key exclusion criteria
Patients who cannot give consent
Patients unable to see the pseudo-window due to mental illness or visual impairment
Patients who have been admitted to another ward and transferred to a bed in the study
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8521
Address
Shijo-machi
TEL
0744368521
nwnh0131@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | Ida |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8521
Address
Shijo-machi
TEL
0744368521
Homepage URL
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
840 Shijo, kashihara, nara
Tel
0744368521
nwnh0131@yahoo.co.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 | 07 | 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
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043953
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
