UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Family suport Program anevaluation for family caregiveres of person of people with dementia
Title of the study (Brief title)	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	Michie Baba
Organization	Fukuoka University
Division name	Faculty of Medicine, School of Nursing
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	Michie Baba
Organization	Fukuoka University
Division name	Faculty of Medicine, School of Nursing
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 12 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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