UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059260 |
|---|---|
| Receipt number | R000067774 |
| Scientific Title | Factors Influencing the Living Environment of Children with Severe Physical and Mental Disabilities: An Interview Survey of Primary Caregivers |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/01 16:47:06 |
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Basic information
Public title
Factors Influencing the Living Environment of Children with Severe Physical and Mental Disabilities: An Interview Survey of Primary Caregivers
Acronym
Factors Influencing the Living Environment of Children with Severe Physical and Mental Disabilities: An Interview Survey of Primary Caregivers
Scientific Title
Factors Influencing the Living Environment of Children with Severe Physical and Mental Disabilities: An Interview Survey of Primary Caregivers
Scientific Title:Acronym
Factors Influencing the Living Environment of Children with Severe Physical and Mental Disabilities: An Interview Survey of Primary Caregivers
Region
| Japan |
Condition
Condition
Children with severe physical and mental disabilities
Classification by specialty
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study identifies barriers recognized by primary caregivers in expanding the living space of children with severe physical and mental disabilities through interview surveys. By clarifying factors related to expanding the living space of children with severe physical and mental disabilities, this research may contribute to realizing physical therapy interventions from new perspectives for expanding their living space.
Basic objectives2
Others
Basic objectives -Others
Previous research on living spaces has focused extensively on adults, the elderly, and persons with disabilities, but little exists targeting children with severe physical and mental disabilities. Children with severe physical and mental disabilities face significant difficulties in moving independently and expanding their living space, suggesting that caregivers play a major role in shaping their living environment. To expand the living space of children with severe physical and mental disabilities, interventions targeting the :environmental factors: category in the ICF ;International Classification of Functioning; are considered effective. Conversely, expanding living space through interventions targeting :body functions: has been deemed unlikely. Therefore, this study views caregivers of children with severe physical and mental disabilities as a crucial :environmental factor: and proceeds accordingly.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conduct interviews with caregivers of children with severe physical and mental disabilities to identify the relationship between the living spaces of these children and their surrounding factors. Perform content analysis based on the extracted data to organize these relationships.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Age] Children with severe physical and mental disabilities: Preschoolers (age 6 and under) Caregivers: Any age
[Gender] Any
[Number] Not specified (Aims for theoretical saturation, maximum approximately 10 participants)
[Target Conditions] Preschool children with severe physical and mental disabilities, and their primary caregivers
(Children with severe physical and mental disabilities are defined by the Ministry of Health, Labour and Welfare as "a group with severe intellectual disabilities combined with severe physical disabilities requiring constant medical care.")
[Facility] Ibaraki Prefectural Medical University Hospital: 1 facility
[Inclusion Criteria] Primary caregivers of children with severe physical and mental disabilities (preschool age) who are outpatient or inpatient at Ibaraki Prefectural Medical University Hospital
Key exclusion criteria
Childcare providers for school-age children
Rationale: Attendance at educational facilities is likely to significantly impact the living environment, and to avoid mixing preschoolers with school-age children.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Minenao |
| Middle name | |
| Last name | Sasahara |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Graduate School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki Prefecture
TEL
09065403375
prover3917@gmail.com
Public contact
Name of contact person
| 1st name | Minenao |
| Middle name | |
| Last name | Sasahara |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Graduate School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki Prefecture
TEL
09065403375
Homepage URL
prover3917@gmail.com
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University Helth of Science Ethics Review Committee
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki Prefecture
Tel
029-888-4000
webmaster@ipu.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
| 2025 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Methods
This study utilizes data from research collaborators within the Rehabilitation Support System at Ibaraki Prefectural Medical University Hospital, along with interviews, to clarify the relationship between the living environments of children with severe physical and mental disabilities and their surrounding factors.
Medical Record Review Method and Data Acquisition
* Medical record review will commence after obtaining approval from the Ibaraki Prefectural Medical University Ethics Committee and further approval for research use from Ibaraki Prefectural Medical University Hospital.
[Analysis Method]
The researcher will conduct content analysis on the data obtained, focusing on the child's living environment and related factors.
Berelson's content analysis method will be adopted for the content analysis technique.
- Grasp the entire description in contextual units
- Use sentences containing one item as the recording unit
- Classify and name individual recording units based on similarity of meaning content using the KJ method, in collaboration with research team members with deep understanding of content analysis
- Quantitatively describe frequency and trends for each categorized and named category
- Verify the reliability of the classified codes by confirming inter-coder agreement with multiple research collaborators
- Objectively and systematically analyze the explicitly communicated content
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067774
