UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014308 |
|---|---|
| Receipt number | R000016661 |
| Scientific Title | Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2016/06/27 17:19:24 |
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Basic information
Public title
Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Acronym
Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Scientific Title
Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Scientific Title:Acronym
Effectiveness of early inteventions for BPSD in nursing facilities and general hospitals
Region
| Japan |
Condition
Condition
care staffs for dementia
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among the staffs caring for a dementia, we would like to elucidate whether a care burden feelings of the staffs who use the Guidelines "early period of BPSD correspondence guidelines" (in Hideyuki Hattori supervision, life science company, 2012) is going to be more reduced in comparison with the persons who does not use it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Japanese version-Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Key secondary outcomes
Japanese version-Maslach Burnout Inventory (MBI)
Japanese version-Care Dependency Scale (CDS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Staffs are going to care patients with dementia using "BPSD initial correspondence guidelines" (Hideyuki Hattori supervision, life science company, 2012) for one month.
Interventions/Control_2
Staffs are going to care patients with dementia without using "BPSD initial correspondence guidelines" (Hideyuki Hattori supervision, life science company, 2012) for one month.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Care persons, nurses, occupational therapists, the clinical psychologists who works for nursing facility (care health center for the elderly, care old man welfare institution, group home) and a general hospital
Key exclusion criteria
Persons having a specialized qualification about dementia such as dementia authorization (registered) nurses
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Hattori |
Organization
National Center for Gerontology and Geriatrics
Division name
Psychiatry
Zip code
Address
35 Morioka-Gengo, OObu city, Aichi prefecture, Japan
TEL
0562-46-2311
hideyuki@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Fukuda |
Organization
National Center for Gerontology and Geriatrics
Division name
Psychiatry
Zip code
Address
35 Morioka-Gengo, OObu city, Aichi prefecture, Japan
TEL
0562-46-2311
Homepage URL
kojifkd@ncgg.go.jp
Sponsor or person
Institute
National Center for Gerontology and Geriatrics
Institute
Department
Personal name
Funding Source
Organization
National Center for Gerontology and Geriatrics
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
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
| 2014 | Year | 06 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016661
