UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050094 |
|---|---|
| Receipt number | R000057068 |
| Scientific Title | Effectiveness of a Combined Reminiscence Therapy, Coffee Therapy, and Activities of Daily Living Practice Intervention for Older People with Moderate-to-Severe Alzheimer's Disease: A Retrospective Time Series Study |
| Date of disclosure of the study information | 2023/01/22 |
| Last modified on | 2023/01/21 11:37:03 |
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Basic information
Public title
Effectiveness of a Combined Reminiscence Therapy, Coffee Therapy, and Activities of Daily Living Practice Intervention for Older People with Moderate-to-Severe Alzheimer's Disease: A Retrospective Time Series Study
Acronym
Effectiveness of a Combined Intervention for Older People with Alzheimer's Disease
Scientific Title
Effectiveness of a Combined Reminiscence Therapy, Coffee Therapy, and Activities of Daily Living Practice Intervention for Older People with Moderate-to-Severe Alzheimer's Disease: A Retrospective Time Series Study
Scientific Title:Acronym
Effectiveness of a Combined Intervention for Older People with Alzheimer's Disease
Region
| Japan |
Condition
Condition
Alzheimer's Disease
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effectiveness of a combined intervention combining reminiscence therapy, coffee therapy, and activities of daily living practice for older people with moderate-to-Severe alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ABC Dementia Scale
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using an AB design, participants participated in usual care in phase A and an intervention that combined reminiscence therapy, coffee therapy, and activities of daily living practice in phase B.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The participants were three older people (all women) with stage 2 or 3 Alzheimer's disease as rated by the Clinical Dementia Rating instrument who participated in a combined intervention of reminiscence therapy, coffee therapy, and ADL practice as a day service initiative between December 2021 and May 2022.
Key exclusion criteria
A person who does not have moderate to severe Alzheimer's disease. Those who have difficulty participating in the intervention.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
yorozuya@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh University
Division name
Faculty of Care and Rehabilitation
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
Homepage URL
yorozuya@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Kyosuke Yorozuya
Funding Source
Organization
Seijoh 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
the Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai, Aichi
Tel
0526016000
fujita@seijoh-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 22 | 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
3
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057068
| 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 |
