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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | major and mild neurocognitive disorder | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 14 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |