UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018341 |
|---|---|
| Receipt number | R000021220 |
| Scientific Title | The effect of preventive program of Hospitalization-associated disability |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2018/04/09 18:37:41 |
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Basic information
Public title
The effect of preventive program of Hospitalization-associated disability
Acronym
The effect of preventive program of Hospitalization-associated disability
Scientific Title
The effect of preventive program of Hospitalization-associated disability
Scientific Title:Acronym
The effect of preventive program of Hospitalization-associated disability
Region
| Japan |
Condition
Condition
Hospitalization-associated disability
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study provides early rehabilitation (rehabilitation by the patients itself, the nurse, or a physiotherapist) for the high-risk person of a hospitalization-associated disability, and investigates the preventive effect based on change of activities of daily living or a cognitive function. Furthermore, we examine the difference of the incidence rate of a hospitalization-associated disability by comparison of a treatment as usual group and a hospitalization-associated disability preventive program intervention group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity daily living
Cognitive function
The level of need for nursing care
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
rihabilitation
Interventions/Control_2
treatment as usual
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An inpatient aged 55 and over
Key exclusion criteria
cognitive function decline
The patient who cannot carry out the test
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kotegawa |
Organization
Ehime univercity hospital
Division name
Total medical support center
Zip code
Address
454, Shitsukawa, Toon City
TEL
089-960-5917
kotegawa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kotegawa |
Organization
Ehime univercity hospital
Division name
Total medical support center
Zip code
Address
454, Shitsukawa, Toon City
TEL
089-960-5917
Homepage URL
kotegawa@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime univercity
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2015 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 17 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021220
| 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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