UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031320 |
|---|---|
| Receipt number | R000035750 |
| Scientific Title | Life support program for elderly with mild cognitive impairment by occupational therapist to learn strategies to keep daily life independently: preliminary study |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2021/02/19 15:01:55 |
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Basic information
Public title
Life support program for elderly with mild cognitive impairment by occupational therapist to learn strategies to keep daily life independently: preliminary study
Acronym
Preliminary study on development of life support program for elderly with mild cognitive impairment
Scientific Title
Life support program for elderly with mild cognitive impairment by occupational therapist to learn strategies to keep daily life independently: preliminary study
Scientific Title:Acronym
Preliminary study on development of life support program for elderly with mild cognitive impairment
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the feasibility and usefulness of the life support program for elderly with mild cognitive impairment by occupational therapist
Basic objectives2
Others
Basic objectives -Others
Development of the life support program for elderly with mild cognitive impairment by occupational therapist
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Goal Attainment Scaling
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implement a questionnaire about memory problems in daily life, select an ADL task to be addressed by the program, and educate new way using memory aid
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
People who live at home; People suspected of cognitive impairment; People with family members to cooperate in the research
Key exclusion criteria
Mini Mental State Examination-Japanese (MMSE-J) Score < 21; MMSE-J score = 30; No ADL tasks to be addressed by the program
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | KAMIMURA |
Organization
Shinshu University
Division name
School of health sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano Pref. Japan
TEL
09041088417
tkamimu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | KAMIMURA |
Organization
Shinshu University
Division name
School of health sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano Pref. Japan
TEL
0263-37-2395
Homepage URL
tkamimu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Shinshu University
Address
3-1-1 Asahi Matsumoto JAPAN
Tel
0263-37-2574
mdrinri@shinshu-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
北アルプス医療センターあづみ病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035750
| 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 |
