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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044172
Receipt No. R000050422
Scientific Title Family Empowerment Programs for Caregivers of Children with Disabilities at Home
Date of disclosure of the study information 2021/05/19
Last modified on 2021/11/10

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Basic information
Public title Family Empowerment Programs for Caregivers of Children with Disabilities at Home
Acronym Family Empowerment Programs for Caregivers of Children with Disabilities at Home
Scientific Title Family Empowerment Programs for Caregivers of Children with Disabilities at Home
Scientific Title:Acronym Family Empowerment Programs for Caregivers of Children with Disabilities at Home
Region
Japan

Condition
Condition Caregivers rearing the children with disabilities
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine whether a family empowerment program for caregivers who raise children with disabilities at home has the effect of reducing the burden on them, promoting the utilization of social resources, increasing self-compassion, and increasing family empowerment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes family empowerment
Key secondary outcomes Care burden
Self-compassion
Awareness of the utilization of social resources
QOL of the main caregiver

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are 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 Other
Interventions/Control_1 Intervention group(Intervention period is 4 weeks)
1st week
1) Explain the outline of Family Empowerment
2) Through the creation and sharing of eco-maps, raise awareness of the three levels of Family Empowerment (FA / SS / SP)
2nd week
1) Encourage preparation for using Family Empowerment(Part1)
2) Review and share the week's life with each other
3) Have an opportunity to think about issues in your current life and your desired life
3) Ask participants to look back on the current situation of their children and their families
3rd week
1) Encourage preparation for using Family Empowerment(Part2)
2) Set specific goals for their desired life
3) Have participants share the goals set in 2)
4th week
1) Encourage the use of Family Empowerment
2) Presenting how it was to act toward a specific goal for the desired life, focusing on "concrete changes in life" and "self-evaluation", and praise and comments from other participants
The control group waits for the intervention period of the intervention group.
Interventions/Control_2 The waiting control group will be given the same intervention as the intervention group for 4 weeks.During this period, the intervention group does nothing.
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 Caregivers raising children with disabilities at home
Key exclusion criteria Those who do not have internet environment and device, Those who cannot read and write Japanese
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Rie
Middle name
Last name Wakimizu
Organization University of Tsukuba
Division name Division of Health Innovation and Nursing, Faculty of Medicine
Zip code 305-8575
Address 1-1-1, Tennodai, Tsukuba-city
TEL 029-853-3427
Email riewaki@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Rie
Middle name
Last name Wakimizu
Organization University of Tsukuba
Division name Division of Health Innovation and Nursing, Faculty of Medicine
Zip code 305-8575
Address 1-1-1, Tennodai, Tsukuba-city
TEL 029-853-3427
Homepage URL https://shouni-kazoku.jp/update/research/55
Email riewaki@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Faculty of Medicine
Institute
Department

Funding Source
Organization the Grant-in-Aid for Scientific Research (B) from the Ministry of Education, Culture, Sports, Science, and Technology, Japan (18H03093)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Tsukuba
Address 1-1-1, Tennodai, Tsukuba-city
Tel 0298533427
Email riewaki@md.tsukuba.ac.jp

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
2021 Year 05 Month 19 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 No longer recruiting
Date of protocol fixation
2019 Year 08 Month 22 Day
Date of IRB
2019 Year 08 Month 22 Day
Anticipated trial start date
2021 Year 04 Month 03 Day
Last follow-up date
2021 Year 12 Month 27 Day
Date of closure to data entry
2022 Year 01 Month 31 Day
Date trial data considered complete
2022 Year 02 Month 28 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 11 Day
Last modified on
2021 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050422

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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