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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033621
Receipt No. R000037481
Scientific Title Verification of the Holistic BPSD Care System intevation
Date of disclosure of the study information 2018/08/31
Last modified on 2018/08/03

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Basic information
Public title Verification of the Holistic BPSD Care System intevation
Acronym Verification of the Holistic BPSD Care System intevation
Scientific Title Verification of the Holistic BPSD Care System intevation
Scientific Title:Acronym Verification of the Holistic BPSD Care System intevation
Region
Japan

Condition
Condition demmentia
Classification by specialty
Geriatrics Neurosurgery Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verificatuion of the Holistic BPSD Care System intervation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes BPSD (before and after one,three and five weeks)
Key secondary outcomes Deliriumu,QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervation term:before and after"one,three and five weeks"
Care protocol:Holistic BPSD Care System
Interventions/Control_2 Non intervation term:before and after"one,three and five weeks"
Care protocol:Nomal 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
60 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1.the degree of independence in dementia elderly(more than 2)2.BPSD(more than NPI-Q 3points)

Key exclusion criteria metal disease,intractable neurological disease
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Uchida
Organization Gunma University
Division name Graduate School of Health Sciences
Zip code
Address 3-39-22 Showa-machi,Maebashi-shi,Gunma
TEL 0272208931
Email yuchida@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gunma Univertity Hospital
Organization Gunma University
Division name Clinical Investigation and Reserch Unit
Zip code
Address 3-39-22 Showa-machi,Maebashi-shi,Gunma
TEL 027220-8931
Homepage URL
Email yuchida@gunma-u.ac.jp

Sponsor
Institute Ministry of Education
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 091-05
Org. issuing International ID_1 091-05
Study ID_2 2018-024
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 公益財団法人脳血管研究所附属美原記念病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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