UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030306 |
|---|---|
| Receipt number | 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 09:32:17 |
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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
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
mbaba@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034611
