UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053722 |
|---|---|
| Receipt number | R000061304 |
| Scientific Title | Effect of an onomatopoeia encouraging fluid drinking in an older dementia patient unresponsive to prompts: an N-of-1 trial |
| Date of disclosure of the study information | 2024/02/27 |
| Last modified on | 2024/02/27 11:30:03 |
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Basic information
Public title
Effect of an onomatopoeia encouraging fluid drinking in an older dementia patient unresponsive to prompts: an N-of-1 trial
Acronym
Effect of an onomatopoeia encouraging fluid drinking in an older dementia patient unresponsive to prompts: an N-of-1 trial
Scientific Title
Effect of an onomatopoeia encouraging fluid drinking in an older dementia patient unresponsive to prompts: an N-of-1 trial
Scientific Title:Acronym
Effect of an onomatopoeia encouraging fluid drinking in an older dementia patient unresponsive to prompts: an N-of-1 trial
Region
| Japan |
Condition
Condition
Older dementia patients unresponsive to prompts to drink fluids
Classification by specialty
| Geriatrics | Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether elderly women with dementia who do not readily drink fluids can drink fluids faster when prompted to do so by the onomatopoeia "gokkun, gokkun".
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to finish drinking a cup of water
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Each time the subject put the cup to his/her lips, from that moment until he/she finished drinking the fluid, the person serving the cup says "Gokkun, gokkun" in accordance with the timing of swallowing the fluid.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Dementia Patients regularly visiting Mima Municipal Koyadaira Clinic
2) Patients refusing to drink water and having history of visiting emergency room due to dehydration
Key exclusion criteria
1) Patients decided not to be participated in this study by the lead principal investigator
2) Patients not having legally authorized representative
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fujiwara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL
+81-75-641-9161
syfujiwara@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Fujiwara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL
+81-75-641-9161
Homepage URL
syfujiwara@jichi.ac.jp
Sponsor or person
Institute
Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
Tel
+81-75-641-9161
syomuhan@kyotolan.hosp.go.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
| 2024 | Year | 02 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061304
| 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 |
