UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030564 |
|---|---|
| Receipt number | R000034896 |
| Scientific Title | Analysis of the effect of group cooking activities on elderly inpatient with cognitive impairment and depression |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/07/12 09:18:34 |
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Basic information
Public title
Analysis of the effect of group cooking activities on elderly inpatient with cognitive impairment and depression
Acronym
Analysis of the effect of group cooking activities on elderly inpatient with cognitive impairment and depression
Scientific Title
Analysis of the effect of group cooking activities on elderly inpatient with cognitive impairment and depression
Scientific Title:Acronym
Analysis of the effect of group cooking activities on elderly inpatient with cognitive impairment and depression
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether improvement of depression, social isolation and self-esteem of elderly inpatient with cognitive impairment and depression by group cooking activities
Basic objectives2
Others
Basic objectives -Others
To clarify what factors of group cooking activities for elderly inpatient with cognitive impairment and depression are effective for depression improvement
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Geriatric depression scale 15
(evaluate at hospitalization and 4 weeks after hospitalization)
Key secondary outcomes
the Japanese version of the abbreviated Lubben Social Network Scale, Rosenberg Self-Esteem Scale
(evaluate at hospitalization and 4 weeks after hospitalization)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group participate in group cooking activities consisting of 40 minutes, twice a week, eight session. Usual physical therapy or occupational therapy is replaced by some group cooking activities.
Interventions/Control_2
Only usual physical therapy and occupational therapy are performed.
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
The subjects is elderly inpatiants in the post acute rehabilitation unit those who meet all of the following ; 1. those who agree on participation in group cooking activities and this research, 2. those who have physical functions that can perform cooking activities on both upper limbs, 3. 65 years of age or more, 4. Mini-Mental State Examination during the investigation period is 10 points or more and 23 points or less, 5. Those who make errors in the cube copying test or the clock drawing test, 6. Geriatric depression scale 15 is 4 points or more.
Key exclusion criteria
Elderly inpatiants who can not complete assessment such as Mini-Mental State Examination and Geriatric depression scale 15.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Tokai Memorial Hospital
Division name
Department of Rehabilitation
Zip code
4870031
Address
681-47 Hazama, Kasugai City, Aichi 487-0031
TEL
0568-88-0568
yutakubo916@outlook.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Tokai Memorial Hospital
Division name
Department of Rehabilitation
Zip code
4870031
Address
681-47 Hazama, Kasugai City, Aichi 487-0031
TEL
0568-88-0568
Homepage URL
yutakubo916@outlook.com
Sponsor or person
Institute
Graduate School of Human Life Science, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Human Life Science, Osaka City University
Address
3-3-138 Sugimoto Sumiyoshi-ku, Osaka 558-8585, Japan
Tel
06-6605-2801
okada_s@life.osaka-cu.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
| 2018 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034896
| 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 |
