UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055727 |
|---|---|
| Receipt number | R000063689 |
| Scientific Title | Affinity Motive Scale: Development of a Version for Elderly People in Need of Care |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/10/03 17:19:47 |
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Basic information
Public title
Affinity Motive Scale: Development of a Version for Elderly People in Need of Care
Acronym
Affinity Motive Scale: Development of a Version for Elderly People in Need of Care
Scientific Title
Affinity Motive Scale: Development of a Version for Elderly People in Need of Care
Scientific Title:Acronym
Affinity Motive Scale: Development of a Version for Elderly People in Need of Care
Region
| Japan |
Condition
Condition
Elderly persons requiring nursing care who use daytime rehabilitation services
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a factor analysis of the Affinity Motive Measurement Scale, an evaluation of social rewards obtained through contact with others, from medical data (information associated with the provision of day-care rehabilitation under the care insurance) for elderly people who require nursing care (hereafter, day-care rehabilitation), and whether the scale is applicable to elderly people who require nursing care To clarify.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Basic information (age, gender, weight, main illness, presence of psychiatric disorders such as depression and anxiety, independence in daily living for the elderly with disabilities, household, percentage of long-term care insurance, etc.) 2) Charlson comorbidity index 3) Physical function (degree of walking independence) 5) Social support (short version of social support scale) 6) Affinity motivation scale 7) Questions about group rehabilitation (whether group rehabilitation is desired or not)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: 65 years old or older 2) Gender: any gender 3) I or no problem with independence in daily living for elderly with dementia
Key exclusion criteria
1) Those who refused to participate in this study 2) Those who had significant visual or hearing impairment 3) Those who need acute medical management 4) Those who are in the terminal stage or receiving palliative care 5) Those whose native language is not Japanese 6) Those who have difficulty in completing the questionnaire due to cognitive impairment such as dementia or higher brain dysfunction
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kato |
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kato |
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Tatung Life Housheng Business Group
Institute
Department
Personal name
Funding Source
Organization
Tatung Life Housheng Business Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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
| 2024 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items will be surveyed and the data will be used for this study. These are all items that are performed in routine medical care, and their frequency is equivalent to that of routine medical care. 1) Basic information (age, gender, weight, main illness, presence of psychiatric disorders such as depression and anxiety, independence in daily living for the disabled elderly, household, and percentage of long-term care insurance) 2) Charlson comorbidity index 3) Physical function (degree of walking independence) 4) Cognitive function (degree of independence in daily living for the elderly with cognitive 5) Social support (short version of social support scale) 6) Affinity motivation scale 7) Questions about group rehabilitation (whether group rehabilitation is desired or not)
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063689
