UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for the effect of the dementia caregiver's classroom on caregiver's burden and depression. Cohort study.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hirofumi Sakurai
Organization	Tokyo Medical University Hospital
Division name	Geriatric Medicine
Address	6-7-1, Nishishinjuku, Shinjuku, Tokyo
TEL	03-3342-6111
Email	sakurah@tokyo-med.ac.jp

Public contact
Name of contact person	Hideyuki Terayama
Organization	Tokyo Medical University Hospital
Division name	Geriatric Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016769