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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025423
Receipt No. R000029265
Scientific Title Effects of a simple intervention aimed at reducing the burden on the caregivers of at-home elderly people with dementia
Date of disclosure of the study information 2017/02/01
Last modified on 2019/01/04

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Basic information
Public title Effects of a simple intervention aimed at reducing the burden on the caregivers of at-home elderly people with dementia
Acronym Effects of a simple intervention aimed at reducing the burden on the caregivers of at-home elderly people with dementia
Scientific Title Effects of a simple intervention aimed at reducing the burden on the caregivers of at-home elderly people with dementia
Scientific Title:Acronym Effects of a simple intervention aimed at reducing the burden on the caregivers of at-home elderly people with dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To conduct a intervention aimed at reducing caregiver burden on both caregivers of at-home elderly people with dementia and community professionals, and discuss the effects of simple support methods
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Caregiver Burden(first survey at the baseline, one month later, two month later)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 At one month after the initial survey (baseline), the study cooperators conduct a intervention
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Caregivers of at-home elderly people with dementia (score for the Short-Memory Questionnaire: less than 39 points) using home care support service providers
2.Caregivers aged 20 years or older
3.Individuals who care for at-home elderly people with dementia for more than one hour per day
4.Caregivers who are able to provide written consent with a full understanding of the study
Key exclusion criteria 1.When the elderly person with dementia cared for by the candidate subject has a severe and life-threatening disease, or is in the terminal phase (the person is clinically expected to die within several weeks to six months due to an incurable disease)
2.When the caregiver has a life-threatening disease
3.When a study cooperator determines that the caregiver has difficulty participating in the study, for reasons such as an acute exacerbation of the disease condition of the caregiver's patient, the usage of a care facility by the caregiver's patient, or worsening of the caregiver's health condition
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Kajiwara
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 0822575377
Email kkaji@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Kajiwara
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 0822575377
Homepage URL
Email kkaji@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 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 Completed
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2019 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029265

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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