UMIN-CTR Clinical Trial

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
Email	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
Email	yumi@rehab.osakafu-u.ac.jp

Sponsor
Institute	Osaka Prefecture University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021074