UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048579 |
|---|---|
| Receipt number | 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 | 2024/03/21 10:59:41 |
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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
252-0327
Address
1-15-1 Kitasato, Sagamihara City, Kanagawa Prefecture
TEL
0427789822
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
252-0373
Address
1-15-1 Kitasato, Sagamihara City, Kanagawa Prefecture
TEL
0427789822
Homepage URL
furuya@nrs.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasto University
Institute
Department
Personal name
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
1-15-1 Kitasato, Sagamihara City, Kanagawa Prefecture
Tel
0427789281
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
6
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
Completed
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 | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
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
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055301
