UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040108 |
|---|---|
| Receipt number | 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 | 2023/04/14 11:10:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
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
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
131
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now writing.
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
| 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
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.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 |
