UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029798 |
|---|---|
| Receipt number | R000034048 |
| Scientific Title | A multicenter, randomized controlled trial to assess the effectiveness of falls prevention intervention in discharged older patients |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2021/08/17 15:52:43 |
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Basic information
Public title
A multicenter, randomized controlled trial to assess the effectiveness of falls prevention intervention in discharged older patients
Acronym
A multicenter, randomized controlled trial to assess the effectiveness of falls prevention intervention in discharged older patients
Scientific Title
A multicenter, randomized controlled trial to assess the effectiveness of falls prevention intervention in discharged older patients
Scientific Title:Acronym
A multicenter, randomized controlled trial to assess the effectiveness of falls prevention intervention in discharged older patients
Region
| Japan |
Condition
Condition
Orthopedic patients
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Falls prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Falls during the 30-days period after discharge
Key secondary outcomes
Near-Falls during the 30-days period after discharge
Fear of falling
Physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Usual care
Interventions/Control_2
Falls prevention intervention using home floor plans
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
Discharged orthopedic patients who experienced >1 fall in the past year
Key exclusion criteria
1) MMSE (Mini-Mental State Examination) <18
2) Visual disorders
3) Planning to move within the next month
4) participation refusal
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ueda |
Organization
Yao tokushukai general hospital
Division name
Department of Rehabilitation
Zip code
581-0011
Address
1-17, Wakakusacho, Yao-City, Osaka
TEL
072-993-8501
tetsu6up@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ueda |
Organization
Yao tokushukai general hospital
Division name
Department of Rehabilitation
Zip code
581-0011
Address
1-17, Wakakusacho, Yao-City, Osaka
TEL
072-993-8501
Homepage URL
tetsu6up@yahoo.co.jp
Sponsor or person
Institute
Yao tokushukai general hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Uji tokushukai medical center
Shonan fujisawa tokushukai hospital
Chiba-nishi general hospital
Narita tomisato tokushukai hospital
Nozaki tokushukai hospital
Hanyu general hospital
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Mirai Iryo Research Center Inc.
Address
1-8-7 Koujimachi, Chiyoda-ku, Tokyo 3rd floor of Emina Building
Tel
03-3263-4801
03-3263-4802
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
宇治徳洲会病院（京都府）、湘南藤沢徳洲会病院（神奈川県）、千葉西総合病院（千葉県）、成田富里徳洲会病院（千葉県）、野崎徳洲会病院（大阪府）、羽生総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
72
Results
The falls prevention intervention using home floor plans was effective in preventing falls and near-falls in discharged patients.
Results date posted
| 2021 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Orthopedic patients
Participant flow
Participants were randomized into one of the following groups: intervention group and control group. The physical therapist conducted falls prevention intervention prior to hospital discharge.
Adverse events
N/A
Outcome measures
Falls and near-falls
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034048
| 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 |
