UMIN-CTR Clinical Trial

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
Email	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
Email	tetsu6up@yahoo.co.jp

Sponsor
Institute	Yao tokushukai general hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034048