UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018223 |
|---|---|
| Receipt number | R000021084 |
| Scientific Title | Effectiveness and cost-effectiveness of learning therapy for prevention of the progress of care needs |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2017/07/08 17:46:55 |
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Basic information
Public title
Effectiveness and cost-effectiveness of learning therapy for prevention of the progress of care needs
Acronym
Effectiveness and cost-effectiveness of learning therapy
Scientific Title
Effectiveness and cost-effectiveness of learning therapy for prevention of the progress of care needs
Scientific Title:Acronym
Effectiveness and cost-effectiveness of learning therapy
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily investigate whether learning therapy for the people with dementia in Japan is effective and cost effective or not by analyzing the naturalistic cohort data which includes both experimental and control groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome of this study is the difference of the mean care time between the groups at 6 months after the starting point.
Key secondary outcomes
1. the difference of the mean care time between the groups at 12 months after the starting point.
2. the difference of mean score of MMSE, FAB, EQ-5D at 3, 6, 12 month after the starting point.
3. cost effectiveness with EQ-5D
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- participants should be a user of the long term care insurance and the level of 'ADL of people with dementia' is greater than II ('ADL of people with dementia' is the term used for the assessment in long term care insurance schema in Japan).
- 65 years or older
- consent to participate in writing
- the score of MMSE between 10 and 26
Key exclusion criteria
- difficult to follow up for 6 months after start of observation
- other severe general medical conditions
- judged to be difficult to be involved by the chief researcher with other reason mentioned above.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Mimura |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
mimura@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Kumon Institute of Education Co., Ltd.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumon Institute of Education Co., Ltd.
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
| 2015 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome of this study is the difference of the mean care time between groups at 6 month after starting point.
Secondary outcomes of this study are
- the difference of the mean care time between groups at 12 month after starting point.
- the difference of mean score of MMSE, FAB and EQ-5D between groups at 3, 6, 12 month after starting point.
- cost effectiveness with EQ-5D
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2017 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021084
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
