UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031151 |
|---|---|
| Receipt number | R000035583 |
| Scientific Title | Effectiveness of Group-based Education for Informal Caregivers of People with Dementia in Japan: a randomized controlled study |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2019/09/10 16:21:35 |
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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
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
sumiyami@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035583
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| Registered date | File name |
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