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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014414
Receipt No. R000016769
Scientific Title Research for the effect of the dementia caregiver's classroom on caregiver's burden and depression. Cohort study.
Date of disclosure of the study information 2014/06/29
Last modified on 2016/07/10

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Basic information
Public title Research for the effect of the dementia caregiver's classroom on caregiver's burden and depression. Cohort study.
Acronym Research for dementia caregiver's burden and depression.
Scientific Title Research for the effect of the dementia caregiver's classroom on caregiver's burden and depression. Cohort study.
Scientific Title:Acronym Research for dementia caregiver's burden and depression.
Region
Japan

Condition
Condition Dementia patients and caregivers (families)
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research examines an effect of caregiver's education on dementia patient's BPSD, caregiver's burden, QOL and depression, through the research to the caregivers who participate in classroom, or not.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The Center for Epidemiologic Studies Depression Scale (CES-D)
Baseline, 3 month, 12 month
Key secondary outcomes EuroQol-5D, Zarit Burden Interview (ZBI), ADL, Neuropsychiatric Inventory (NPI)
Baseline, 3 month, 12 month

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients
Key exclusion criteria Patients without family's caregiver.
Caregivers attended to the dementia caregiver's classroom in the past.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Sakurai
Organization Tokyo Medical University Hospital
Division name Geriatric Medicine
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku, Tokyo
TEL 03-3342-6111
Email sakurah@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Terayama
Organization Tokyo Medical University Hospital
Division name Geriatric Medicine
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku, Tokyo
TEL 03-3342-6111
Homepage URL
Email t-hide@tokyo-med.ac.jp

Sponsor
Institute Department of Geriatric Medicine, Tokyo Medical University Hospital
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
Address
Tel
Email

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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 29 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
2014 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 18 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 08 Month 31 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information Observational items:

Patient background
Caregiver's background and care environment
Participant in dementia caregiver's classroom
Mini-Mental State Examination (MMSE)
ADL
The Center for Epidemiologic Studies Depression Scale (CES-D)
EuroQol-5D
Zarit Burden Interview (ZBI)
Neuropsychiatric Inventory (NPI)

Management information
Registered date
2014 Year 06 Month 29 Day
Last modified on
2016 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016769

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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