UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054166 |
|---|---|
| Receipt number | R000061855 |
| Scientific Title | Effectiveness of Implementing an Electronic Version of the Holistic BPSD Care System for Residents Living in a Serviced Senior Housing Facility |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2024/04/16 12:45:04 |
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Basic information
Public title
Effectiveness of Implementing an Electronic Version of the Holistic BPSD Care System for Residents Living in a Serviced Senior Housing Facility
Acronym
Effectiveness of Implementing an Electronic Version of the Holistic BPSD Care System for Residents Living in a Serviced Senior Housing Facility
Scientific Title
Effectiveness of Implementing an Electronic Version of the Holistic BPSD Care System for Residents Living in a Serviced Senior Housing Facility
Scientific Title:Acronym
Effectiveness of Implementing an Electronic Version of the Holistic BPSD Care System for Residents Living in a Serviced Senior Housing Facility
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to cope with the super-aging society in our country, scientific nursing care for dementia, quality evaluation of care, and introduction of ICT are required. Uchida et al. developed an electronic version of the Holistic BPSD Care System(electronic version system) that integrates assessment, care practice, and evaluation for BPSD (behavioral and psychological symptoms of dementia), and its effectiveness was reported through an intervention study that was approved by Gunma University Ethics. This study will examine the use of ICT in elderly housing, expected effects, and system issues through the introduction of the electronic version of the system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Neuropsychiatric Inventory-Questionnaire
Key secondary outcomes
Short version of the Quality of life questionnaire for dementia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The intervention will be conducted primarily by nursing staff using an electronic version of the Holistic BPSD Care System. The intervention period will be 6 months, and assessments will be conducted before the intervention and every month thereafter, measuring the primary outcome measure, BPSD (NPI-Q), and the secondary outcome measure, quality of life ( Short version of QOL-D).
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
About 16 elderly users (or their proxies for those who could not write a consent form) who lived in A serviced housing for the elderly and who gave their consent were selected as study subjects.
Key exclusion criteria
Items for which consent was not obtained
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Gunma University Graduate School
Division name
School of Health Sciences Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
0272208931
yuchida@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Gunma University Graduate School
Division name
School of Health Sciences Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
0272208931
Homepage URL
yuchida@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Gunma University
Address
3-39-22 Showa-machi, Maebashi, Gunma
Tel
0272208931
yuchida@gunma-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HS2023-231
Org. issuing International ID_1
Gunma University
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 | 04 | Month | 16 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | 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 | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061855
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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