UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 23 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 03 Day
Last modified on	2020 Year 07 Month 27 Day

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