UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Group-based Education for Informal Caregivers of People with Dementia in Japan: a randomized controlled study
Acronym	Effectiveness of GMC-PEI for caregivers of People with Dementia
Scientific Title	Effectiveness of Group-based Education for Informal Caregivers of People with Dementia in Japan: a randomized controlled study
Scientific Title:Acronym	Effectiveness of GMC-PEI for caregivers of People with Dementia
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Neurology Geriatrics Psychiatry Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether a group-based multi-component psycho-educational intervention (GMC-PEI) could reduce depression and improve caregiving appraisals, the coping skills of informal caregivers, and the condition of people with dementia (PWD). Moreover, we examined if the benefits of GMC-PEI were sustained.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The stress responses: Depression(The Center for Epidemiologic Studies Depression Scale; CES-D)
Key secondary outcomes	caregiving time, subjective burden, caregiving appraisals, care coping, and PWD condition (cognitive function, ADL, and BPSD).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	A group-based multi-component psycho-educational intervention (GMC-PEI) including six 2-h structured sessions (medical treatment, dementia care, psychology, and social welfare) and lectures on dementia, caregiving, and coping with stress over a 12-week period.
Interventions/Control_2	The control group was given leaflets containing information about dementia.
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	1) be an informal caregiver; 2) informal caregivers do not actively seek immediate nursing home placement; 3) Informal caregiver who received written informed consent and agree to participate in this study; 4) informal caregivers of people diagnosed with and receiving periodic medical examinations for dementia; and 5) an informal caregiver who care for care recipients who do not live in nursing homes or group homes.
Key exclusion criteria	1) be a professional carer; 2) informal caregivers do actively seek immediate nursing home placement; 3) Informal caregiver who received written informed consent and did not agree to participate in this study; 4) informal caregivers of people did not diagnosed with and receiving periodic medical examinations for dementia; and 5) an informal caregiver who care for care recipients who live in nursing homes or group homes.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Aya Middle name Last name Seike
Organization	1:National Center for Geriatrics and Gerontology,2:Kyoto University
Division name	1:The Center for Comprehensive Care and Research on Memory Disorders,2: Kokoro research center
Zip code	6068504
Address	46 Shimoadachi-cho,Yoshida,Sakyo-ku,Kyoto 606-8501 JAPAN
TEL	075-753-9683
Email	seike.aya.6u@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Miyu Middle name Last name Sumiya
Organization	National Center for Geriatrics and Gerontology
Division name	The division of medical research consultation
Zip code	4748511
Address	7-430,Morioka-cho,Ohbu City,Aichi
TEL	0562-46-2311
Homepage URL
Email	sumiyami@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430,Morioka-cho,Ohbu City,Aichi
Tel	0562-46-2311
Email	sumiyami@ncgg.go.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	国立長寿医療研究センター（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 05 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	2013 Year 10 Month 01 Day
Date of IRB	2013 Year 11 Month 29 Day
Anticipated trial start date	2013 Year 11 Month 29 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 01 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2019 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035583