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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048579
Receipt No. R000055301
Scientific Title Development and evaluation of the usefulness of a support program for the siblings of children with severe disabilities under at-home care.
Date of disclosure of the study information 2022/08/05
Last modified on 2022/08/04

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Basic information
Public title Development and evaluation of the usefulness of a support program for the siblings of children with severe disabilities under at-home care.
Acronym Development and evaluation of the usefulness of a support program for the siblings of children with severe disabilities under at-home care.
Scientific Title Development and evaluation of the usefulness of a support program for the siblings of children with severe disabilities under at-home care.
Scientific Title:Acronym Development and evaluation of the usefulness of a support program for the siblings of children with severe disabilities under at-home care.
Region
Japan

Condition
Condition Siblings of children with severe disabilities under at-home care
Classification by specialty
Nursing Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the usefulness of a support program for school aged siblings of children with severe disabilities under at-home care
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peer conscious by a Peer support program
Key secondary outcomes Health-Related Quality of Life in children(7-13 years), (1 month after the end of the program)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Three session of an online support program for the siblings of children with severe disabilities under at-home care
Once a month(90min)
3 Month
Interventions/Control_2
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
8 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria a)Siblings who live with brother/sisters with severe disabilities

b)The siblings without disabilities

c) The siblings who understand the content of this research and agree to participate in the program

A)A parent of the siblings that meet the above three mentioned criteria
Key exclusion criteria Siblings and the parent who disagree to participate in the study
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Etsuyo
Middle name
Last name Furuya
Organization Kitasto University
Division name School of Nursing
Zip code 252-0329
Address 2-1-1 Kitasato, Sagamihara City, Kanagawa Prefecture
TEL 0427789822
Email furuya@nrs.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Etsuyo
Middle name
Last name Furuya
Organization Kitasto University
Division name School of Nursing
Zip code 252-0329
Address 2-1-1 Kitasato, Sagamihara City, Kanagawa Prefecture
TEL 0427789822
Homepage URL
Email furuya@nrs.kitasato-u.ac.jp

Sponsor
Institute Kitasto University
Institute
Department

Funding Source
Organization Kitasto University
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 The Clinical Research Ethics Review Committee of Kitasto University School of Nursing
Address 2-1-1 Kitasato, Sagamihara City, Kanagawa Prefecture
Tel 0427789281
Email ttsukada@kitasato-u.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
2022 Year 08 Month 05 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 Enrolling by invitation
Date of protocol fixation
2022 Year 07 Month 26 Day
Date of IRB
2022 Year 07 Month 26 Day
Anticipated trial start date
2022 Year 08 Month 05 Day
Last follow-up date
2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2022 Year 08 Month 04 Day
Last modified on
2022 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055301

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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