UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048831 |
|---|---|
| Receipt number | R000055642 |
| Scientific Title | Development and Reliability and Validity of the convalescent Version of the Falls Self-Efficacy Scale |
| Date of disclosure of the study information | 2022/09/14 |
| Last modified on | 2022/09/02 14:09:50 |
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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
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
aihara09s@gmail.com
Sponsor or person
Institute
Tohoku Fukushi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055642
| Research Plan | |
|---|---|
| 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 |
