UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047800 |
|---|---|
| Receipt number | R000054494 |
| Scientific Title | Development of a Self-Efficacy Scale for in the Elderly |
| Date of disclosure of the study information | 2022/05/19 |
| Last modified on | 2022/05/19 14:21:40 |
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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
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
mizuesuzuki@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054494
