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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030306
Receipt No. R000034611
Scientific Title Family suport Program anevaluation for family caregiveres of person of people with dementia
Date of disclosure of the study information 2017/12/08
Last modified on 2019/02/16

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Basic information
Public title Family suport Program anevaluation for family caregiveres of person of people with dementia
Acronym Family suport Program anevaluation for family caregiveres of person of people with dementia
Scientific Title Family suport Program anevaluation for family caregiveres of person of people with dementia
Scientific Title:Acronym Family suport Program anevaluation for family caregiveres of person of people with dementia
Region
Japan

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

Objectives
Narrative objectives1 We evaluate the burden of family, the change of feelings about stress,change of degree of depression, the acquisition of stress coping, by family caregivers participationg in the support program, and clarify the effect of the support program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Countermeasure scale against care-taking stress
Key secondary outcomes Zarit Caregiver burden scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Person who receives family support program
Person who receives 6 times for 6 months
Interventions/Control_2 People who do not receive family support program
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria family person who care at the beginning of dementia at home
People with dementia need nursing care 3
Key exclusion criteria People with dementia need nursing care 4,5
person who tend to take a absence
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michie Baba
Organization Fukuoka University
Division name Faculty of Medicine, School of Nursing
Zip code
Address 7-45-1,Nanakuma,Jonann-ku, Fukuoka City
TEL 092-801-1011
Email mbaba@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michie Baba
Organization Fukuoka University
Division name Faculty of Medicine, School of Nursing
Zip code
Address 7-45-1,Nanakuma,Jonann-ku, Fukuoka City
TEL 092-801-1011
Homepage URL
Email mbaba@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization JAPS KAKENHI Grant Number
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 12 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2017 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2019 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034611

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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