UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014414 |
|---|---|
| Receipt number | 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 13:36:42 |
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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
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
t-hide@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Geriatric Medicine, Tokyo Medical University Hospital
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016769
