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

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 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


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

Value
https://center6.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