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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040108
Receipt No. R000045730
Scientific Title Study evaluating effectiveness of special unit for dementia care (Dementia Care Unit); single-center prospective observational study
Date of disclosure of the study information 2020/04/08
Last modified on 2020/04/08

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Basic information
Public title A study evaluating the effectiveness of special unit for dementia care (Dementia Care Unit)
Acronym Effectiveness of DCU
Scientific Title Study evaluating effectiveness of special unit for dementia care (Dementia Care Unit); single-center prospective observational study
Scientific Title:Acronym Effectiveness of DCU; single-center prospective observational study
Region
Japan

Condition
Condition Dementia, Internal medicine
Classification by specialty
Medicine in general Geriatrics Psychiatry
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Stay in the DCU during hospitalization
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Barthel Index at discharge
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who fulfill the following criteria
(1) Patients admitted to the Department of Internal Medicine at Yuaikai Oda Hospital
(2) Patients with age 75 or older
(3) Patients with a level of cognition (level of independence in daily living for the elderly with dementia) of III or higher (IIIa, IIIb, IV, M) on admission.
Key exclusion criteria Patients whose consent to this study was not obtained from themselves or their families
Target sample size 230

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Tago
Organization Saga University Hospital
Division name General Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
TEL 0952-34-3238
Email tagomas@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Tago
Organization Saga University Hospital
Division name General Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
TEL 0952-34-3238
Homepage URL
Email tagomas@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

Funding Source
Organization Nihon-seimei Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Yuai-kai Foundation and Oda Hospital
Address 4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel 0954-63-3275
Email renkei@yuai-hc.jp

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
2020 Year 04 Month 08 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 Enrolling by invitation
Date of protocol fixation
2020 Year 02 Month 14 Day
Date of IRB
2019 Year 12 Month 03 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2021 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The following information is obtained through electronic medical records, interviews, and observations.
Pre-hospitalization: living site, independence in daily living (Bedriddenness rank, cognitive function socre)
At the time of admission: admission category (planned or emergency), qSOFA, independence of daily living, ABC scale, Barthel index, MMSE, antipsychotic medication, sleeping pills, ADL, needs of nursing care (IV, EKG monitoring, etc.), presence of risky behaviors, communication disability.
During hospitalization: number of days of stay in DCU, nurse calls, physical restraints, sleeping hours, nighttime awake hours, incidence of BPSD, etc.
At the time of discharge: length of stay, qSOFA, independence of daily living, ABC scale, Barthel index
On 28 days after discharge: place spent (home, facility, hospital) and number of days, readmission, independence of daily living

Management information
Registered date
2020 Year 04 Month 08 Day
Last modified on
2020 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045730

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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