UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045275 |
|---|---|
| Receipt number | R000051712 |
| Scientific Title | Research for the usefulness of day service for Lewy body dementia and its program development |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2025/02/27 16:37:28 |
* 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
Research for the usefulness of day service for Lewy body dementia and its program development
Acronym
Research for the usefulness of day service for Lewy body dementia
Scientific Title
Research for the usefulness of day service for Lewy body dementia and its program development
Scientific Title:Acronym
Research for the usefulness of day service for Lewy body dementia
Region
| Japan |
Condition
Condition
Lewy body disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research for the usefulness of day service
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical symptoms after 6 months
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
| 45 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who meet the diagnostic criteria of McKeith et al (2017)
Key exclusion criteria
Those who died during the study period
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University
Division name
Department of Occupational Therapy School of Health Sciences
Zip code
960-8516
Address
10-6 Sakae- Machi, Fukushima City Fukushima, 960-8515
TEL
0245815555
hhayashi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University
Division name
Department of Occupational Therapy School of Health Sciences
Zip code
960-8516
Address
10-6 Sakae-Machi, Fukushima City Fukushima, 960-8515
TEL
0245815555
Homepage URL
hhayashi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, 960-1295,Japan
Tel
0245471825
fmurec@fmu.ac.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
福島県立医科大学（福島県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
30
Results
The numbers of participants who newly used a day service (DS) by six months later were 13 of 30. The change of J-ZBI scores in DS new user group was not significantly different compared with that in DS non-user.
Results date posted
| 2025 | Year | 02 | Month | 27 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
We analysed the data on thirty participants.
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051712
