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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031956
Receipt No. R000036494
Scientific Title Development comprehensive agile early discharge program for patients with dementia: preliminary study
Date of disclosure of the study information 2018/03/29
Last modified on 2018/03/29

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Basic information
Public title Development comprehensive agile early discharge program for patients with dementia: preliminary study
Acronym Development comprehensive agile early discharge program for patients with dementia: preliminary study
Scientific Title Development comprehensive agile early discharge program for patients with dementia: preliminary study
Scientific Title:Acronym Development comprehensive agile early discharge program for patients with dementia: preliminary study
Region
Japan

Condition
Condition major and mild neurocognitive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preliminary research for the development of Dementia Discharge program in dementia treatment wards
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Length of hospital stay
Daily living activities
Behavioral and Psychological Symptoms of Dementia
Care burden feeling
Nursing care affirmation feeling
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Provide comprehensive support for dementia patients who wish to discharge from their home in a dementia treatment ward. For example, we visit their home early and investigate the living conditions and living environment before admission. And we provide practice and care of daily life skills making use of that information. We also provide assistance in cooperation with many types of occasions, such as "BPSD to family members, guidance on nursing care", "Before discharge hospital day care experience and outdoor practice", if necessary.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient has a diagnosis of dementia
Acceptance of research participation from physicians will be obtained
Patient, family member indicates intention to discharge to home
Acceptance of research participation is obtained from substitute family members
Key exclusion criteria Person who changed intention from retturning home to entering facility
Person who transferred to a hospital for some reason
Person who obviously got lowered body and mind functional level because of new treatment
Respite care
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiaki Sakamoto
Organization Mihara hospital
Division name Occupational therapy room
Zip code
Address 6-31-1 Nakano-cho,Mihara-shi,Hiroshima 723-0003,Japan
TEL 0848-63-8877
Email ots@miharahp.com

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Sakamoto
Organization Mihara hospital
Division name Occupational therapy room
Zip code
Address 6-31-1 Nakano-cho,Mihara-shi,Hiroshima 723-0003,Japan
TEL 0848-63-8877
Homepage URL
Email ots@miharahp.com

Sponsor
Institute Mihara hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 三原病院(広島県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 29 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036494

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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