UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054624 |
|---|---|
| Receipt number | R000062175 |
| Scientific Title | Current Status and Issues of Independence Support Care for Severely Needy Patients |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2024/06/11 07:11:31 |
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Basic information
Public title
Current Status and Issues of Independence Support Care for Severely Needy Patients
Acronym
Current Status and Issues of Independence Support Care for Severely Needy Patients
Scientific Title
Current Status and Issues of Independence Support Care for Severely Needy Patients
Scientific Title:Acronym
Current Status and Issues of Independence Support Care for Severely Needy Patients
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to present the current status of independence-supportive care for persons requiring severe nursing care and to identify what the challenges are
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interviews about one hour with three workers at a special nursing home for the elderly that practices Independence Support Care and a questionnaire survey 6 items of other workers
Questionnaire survey 6 items to workers at nursing homes for the elderly that do not practice it.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A questionnaire survey on attitudes toward caregiving will be conducted among caregivers at facilities that do and do not provide independence-supportive care.
Both the questionnaire survey and the interview survey will be conducted among caregivers at a social welfare corporation in Nagaoka City, where the author works. The questionnaire survey will be conducted with 30 caregivers from special nursing homes that provide regular nursing care and 30 caregivers from special nursing homes that provide independence-support nursing care.
Interventions/Control_2
An interview survey will be conducted with three veteran caregivers (who have been with the company for more than 10 years) at a special nursing home in Nagaoka City. The interviews will be organized by SCAT to summarize the current status and issues of independence support nursing care.
Interview surveys were conducted with three veteran caregivers (employed for 10 years or more) at a special nursing home for the elderly who practice independence-supportive nursing care.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Caregivers with written consent.
Key exclusion criteria
Significant mental health problems.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | yuuya |
| Middle name | |
| Last name | nomura |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Social Welfare Major in Health and Welfare Policy, Planning and Administration
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City
TEL
025-257-4500
swm23102@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | yuuya |
| Middle name | |
| Last name | nomura |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Social Welfare Major in Health and Welfare Policy, Planning and Administration
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City
TEL
025-257-4500
Homepage URL
swm23102@nuhw.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Niigata University of Health and Welfare Graduate School
Address
1398 Shimamicho, Kita-ku, Niigata City
Tel
025-257-4500
swm23102@nuhw.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
| 2024 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 30 | 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
Management information
Registered date
| 2024 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062175
