UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041230 |
|---|---|
| Receipt number | R000046368 |
| Scientific Title | Verrification of the holistic BPSD Care System intervation-Electronic version- |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2024/01/30 09:29:26 |
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Basic information
Public title
Verrification of the holistic BPSD
Care System intervation-Electronic version-
Acronym
Verrification of the holistic BPSD
Care System intervation-Electronic version-
Scientific Title
Verrification of the holistic BPSD
Care System intervation-Electronic version-
Scientific Title:Acronym
Verrification of the holistic BPSD
Care System intervation-Electronic version-
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the holistic BPSD Care System -Electronic version-
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
before and after BPSD level
Key secondary outcomes
before and after QOL level
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
The holistic care system electronic version intervention while two months
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Behavioral and Psychological Symptoms of Dementia client
Key exclusion criteria
Mental illness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
3718514
Address
Showa Maebashi Gunma
TEL
027-220-8931
yuchida@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | tetuya |
| Middle name | |
| Last name | Nakamura |
Organization
Gunma university hospital
Division name
Clinical trial department
Zip code
3718511
Address
Showa Maebashi Gunma
TEL
027-220-8740
Homepage URL
hitotaisho-ciru@ml.gunma-u.ac.jp
Sponsor or person
Institute
Ministry of education
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical trial department Gunma university hospital
Address
Showa Maebashi Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
bpsd.jp
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jdcr/5/0/5_1/_pdf/-char/ja
Number of participants that the trial has enrolled
6
Results
Improvement for BPSD
Results date posted
| 2022 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seniors over 65 years old with dementia
Participant flow
From patients to home care clients
Adverse events
nothing
Outcome measures
NPI-Q,Short-QOL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 29 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046368
