UMIN-CTR Clinical Trial

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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