UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031956 |
|---|---|
| Receipt number | 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 00:12:37 |
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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
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
ots@miharahp.com
Sponsor or person
Institute
Mihara hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036494
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
