UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022330 |
|---|---|
| Receipt number | R000025727 |
| Scientific Title | Effect of dialect, non-dialect for elderly with dementia |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2017/05/19 08:30:22 |
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Basic information
Public title
Effect of dialect, non-dialect for elderly with dementia
Acronym
Effect of words for elderly with dementia
Scientific Title
Effect of dialect, non-dialect for elderly with dementia
Scientific Title:Acronym
Effect of words for elderly with dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We inspect effects of dialect,non-dialect on elderly people with dementia to improve our nursery care. In the current study, their cognitive function and subjective sense of well-being are mainly focused
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences of the score between before the intervention and after two months from it: Mini Mental State Examination (MMSE),Gottfries Brane Steen(GBS) Scale,Philadelphia Geriatric Center(PGC) Moral Scale,Word Fluency Test (WFT),Free conversation in 3 minutes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We have the patients watch RAKUGO and picture-story show in dialect for 15 to 30 minutes twice a week.(2months)
And examine MMSE,PGC Moral Scale,GBS Scale,WFT,Free conversation in 3 minutes, before and after the intervention.
Interventions/Control_2
We have the patients watch RAKUGO and picture-story show in non-dialect for 15 to 30 minutes twice a week.(2months)
And examine MMSE,PGC Moral Scale,GBS Scale,WFT,Free conversation in 3 minutes, before and after the intervention.
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
Male and Female
Key inclusion criteria
1,Elderly people over the age of 65 diagnosed as dementia by a physician
2,Patients with mild to moderate dementia:over 10 points in MMSE
3,Those who can answer "yes" or "no" to the question, such as "Have you ever felt lonely?"
4,Speakers of "Kansai-ben"(a dialect in Kansai region) who spent the language formative years in Kansai region except for Tajima in Hyogo, west area of Tango in Kyoto and Oku-Yoshino in Nara.
Key exclusion criteria
1,Patients with problems in communication
2,Patients with hearing difficulties
3,Dialect speaker except for the "kansai-ben"
4,Patients who are planning to start or change treatment on dementia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayae Kinoshita |
Organization
Kyoto Univesity
Division name
Home medical care nursing
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku Kyoto
TEL
075-753-4300
kinoshita.ayae.6v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukari Torihata |
Organization
Kyoto Univesity
Division name
Home medical care nursing
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku Kyoto
TEL
075-753-4300
Homepage URL
torihata.yukari.65r@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
| 2016 | Year | 06 | 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
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
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025727
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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