UMIN-CTR Clinical Trial

Basic information
Public title	Development and Reliability and Validity of the convalescent Version of the Falls Self-Efficacy Scale
Acronym	Development and Reliability and Validity of the convalescent Version of the Falls Self-Efficacy Scale
Scientific Title	Development and Reliability and Validity of the convalescent Version of the Falls Self-Efficacy Scale
Scientific Title:Acronym	Development and Reliability and Validity of the convalescent Version of the Falls Self-Efficacy Scale
Region	Japan

Condition
Condition	Inpatients in recovery phase rehabilitation wards
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop and test the reliability and validity of a scale measuring fall self-efficacy in patients admitted to a recovery unit.
Basic objectives2	Others
Basic objectives -Others	Reliability, Validity
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Falls Efficacy Scale International
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(Patients subjects) a. Inpatients in recovery phase rehabilitation wards. b. Able to understand the text when responding to the questionnaire. c. Consented to participate in the study. (Medical staff subjects) a. Therapist, Nurse b. Consent to participate in the study.
Key exclusion criteria	Responding to the scale is burdensome. Patients who not consent this study.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Saika Middle name Last name Aihara
Organization	Tohoku Fukushi University
Division name	Department of Rehabilitation, Faculty of Health Science
Zip code	9818522
Address	1-8-1 Kunimi, Aoba-ku, Sendai City, Miyagi
TEL	022-233-3111
Email	aihara09s@gmail.com

Public contact
Name of contact person	1st name Saika Middle name Last name Aihara
Organization	Tohoku Fukushi University
Division name	Department of Rehabilitation, Faculty of Health Science
Zip code	9818522
Address	1-8-1 Kunimi, Aoba-ku, Sendai City, Miyagi
TEL	022-233-3111
Homepage URL
Email	aihara09s@gmail.com

Sponsor
Institute	Tohoku Fukushi University
Institute
Department

Funding Source
Organization	Tohoku Fukushi University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Bay Rehabilitation Hospital Fujita Health University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Tokyo Bay Rehabilitation Hospital
Address	4-1-1 Yatsu, Narashino-shi, Chiba
Tel	047-453-9000
Email	shinsakai@wanreha.net

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	東京湾岸リハビリテーション病院（千葉県）

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 14 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	Enrolling by invitation
Date of protocol fixation	2021 Year 07 Month 21 Day
Date of IRB	2021 Year 07 Month 21 Day
Anticipated trial start date	2022 Year 09 Month 15 Day
Last follow-up date	2024 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

A questionnaire will be administered to patients and medical staff admitted to the recovery phase rehabilitation ward. The questionnaire items included the recovery version of the Falls Self-Efficacy Scale, the Falls Efficacy Scale International Version (FES-I), the Falls Risk VAS, the Japanese version of the Morse Falls Scale (MFS), and a face sheet. The results will be used to examine item validity, construct validity, internal consistency, retest reliability, inter-rater reliability, criterion-related validity, and cutoff value calculation validity.

Management information
Registered date	2022 Year 09 Month 02 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055642