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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030564
Receipt No. 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 2019/06/28

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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
Email 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
Email yutakubo916@outlook.com

Sponsor
Institute Graduate School of Human Life Science, Osaka City University
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 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
2017 Year 12 Month 26 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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