UMIN-CTR Clinical Trial

Basic information
Public title	Development of a Self-Efficacy Scale for Everyday Living to Elicit Confidence in Living in the Elderly
Acronym	Development of a Self-Efficacy Scale for Everyday Living to Elicit Confidence in Living in the Elderly
Scientific Title	Development of a Self-Efficacy Scale for in the Elderly
Scientific Title:Acronym	Development of a Self-Efficacy Scale for Everyday Living to Elicit Confidence in Living in the Elderly
Region	Japan

Condition
Condition	None (elderly living in the community)
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study was to develop and test the reliability and validity of a self efficacy scale for daily living to elicit confidence in living in elderly people
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Attributes [transcribed from records] 2. 2. Confidence in daily life (interviewed by staff) ADL (Katz) [transcribed from records] 4. Mini-mental State Examination (MMSE) [interviewed by subject] 5. 5. Gottfries-Brane-Steen Scale (GBS scale) [transcribed from records] 6. 6. Questions related to self-efficacy, such as physical pain and distress [interview with the subject]. 7. Subjective Quality of Life Scale for Dementia [subject interviews]. 8. Self-efficacy scale in daily life [interview with the subject]. Translated with www.DeepL.com/Translator (free version)
Key secondary outcomes

Base
Study type	Observational

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	65 years-old <
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who meet all of the following criteria will be included 1) Elderly people who attend day care at Mikatahara Bethel Home, a long-term care health facility for the elderly. 2) Consent for participation in the study has been obtained from the subject 3) Even if they have been diagnosed with dementia, those who correctly answer 2 out of 3 items in the pre-test of the Subjective Quality of Life Survey for Dementia will be included in the study. (Although this study targets the elderly, the elderly in the day-care center include the elderly with dementia, but those who can answer the questions in this study are included in this study. ) The subjects were those who answered correctly on 2 out of 3 items of the pretest of the "Subjective Quality of Life Scale for Dementia" with reference to these previous studies. Note that even if a person was diagnosed with dementia, he or she could respond to the Subjective Quality of Life in Dementia if he or she scored 13 or higher on the MMSE in the authors' study). Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria	Individuals who meet any of the following conditions will not be included in this study. 1) Elderly persons who are physically unwell on the day of the study 2) Elderly patients immediately after discharge from the hospital due to physical illness. 3) Elderly persons who are absent from day care 4) Those who have been diagnosed with dementia but could not answer 2 out of 3 items correctly in the "Subjective Quality of Life with Dementia" pretest. Translated with www.DeepL.com/Translator (free version)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name mizue Middle name Last name suzuki
Organization	Hamamatsu University School of Medicine
Division name	Faculty of Nursing
Zip code	431
Address	1-20-1 Handayama
TEL	+81534352826
Email	mizuesuzuki@gmail.com

Public contact
Name of contact person	1st name mizue Middle name Last name suzuki
Organization	Hamamatsu University School of Medicine
Division name	Faculty of Nursing
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	0534352826
Homepage URL
Email	mizuesuzuki@gmail.com

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel	0534352826
Email	m~suzuki@hama-med.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

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 19 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	Suspended
Date of protocol fixation	2020 Year 12 Month 01 Day
Date of IRB	2021 Year 01 Month 06 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Confidence in daily life [interviewed by staff]. Mini-mental State Examination (MMSE) [Interview survey of the subject]. Questions related to self-efficacy such as physical pain and distress [interviewed by subject]. Subjective Quality of Life Scale for Dementia

Management information
Registered date	2022 Year 05 Month 19 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054494

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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