UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018201 |
|---|---|
| Receipt number | R000021074 |
| Scientific Title | Effects of home visits and environmental modification : a randomized controlled trial- prevention of falls in an acute care hospital |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2022/06/07 18:14:59 |
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Basic information
Public title
Effects of home visits and environmental modification : a randomized controlled trial- prevention of falls in an acute care hospital
Acronym
Effects of home visits and environmental modification : a randomized controlled trial- prevention of falls in an acute care hospital
Scientific Title
Effects of home visits and environmental modification : a randomized controlled trial- prevention of falls in an acute care hospital
Scientific Title:Acronym
Effects of home visits and environmental modification : a randomized controlled trial- prevention of falls in an acute care hospital
Region
| Japan |
Condition
Condition
Orthopedic patiets
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prevention of falls
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of falls
Key secondary outcomes
The number of near-falls
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Usual care
Interventions/Control_2
The guideline of prevention of falls with house sketch
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients to home from acute care hospital with independent gait,and with a history of falls in the previous year
Key exclusion criteria
severe hemiplegia
severe balance disorder
severe vision loss
cognitive function decline
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ueda |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30, Habikino, Habikino City
TEL
0729502111
ueda@rehab.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30, Habikino, Habikino City
TEL
0729502111
Homepage URL
yumi@rehab.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefecture University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yao tokushukai general hospital
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Osaka Prefecture University
Address
3-7-30, Habikino, Habikino City
Tel
0729502111
hiraoka@rehab.osakafu-u.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
八尾徳洲会総合病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2015 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021074
