UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054138 |
|---|---|
| Receipt number | R000061813 |
| Scientific Title | Relationship between perception of healthcare service and health-related quality of life in mothers of children with special need. |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/04/14 12:55:26 |
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Basic information
Public title
Relationship between perception of healthcare service and health-related quality of life in mothers of children with special need.
Acronym
Relationship between perception of healthcare service and health-related quality of life in mothers of children with special need.
Scientific Title
Relationship between perception of healthcare service and health-related quality of life in mothers of children with special need.
Scientific Title:Acronym
Relationship between perception of healthcare service and health-related quality of life in mothers of children with special need.
Region
| Japan |
Condition
Condition
Healthy Subject
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the relationship between parents' perceptions of medical services and their QOL for mothers whose children attend special needs schools.
Basic objectives2
Others
Basic objectives -Others
Observational
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short Form Health Survey (SF-36)
Measure of Processes of Care (MPOC-56)
Key secondary outcomes
mother's sleep status
Mother and child attributes
Children's Activities of Daily Living
Service usage status
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
Mothers of children/students enrolled in special needs schools (elementary schools, junior high schools, high school) in two cities within the prefecture
Key exclusion criteria
Mother who cannot give consent
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Usuda |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8511
Address
3-39-22,Showamachi,Maebashi-shi,Gunma,371-8511,JAPAN
TEL
+81-27-220-8949
susuda@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kazama |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8511
Address
3-39-22,Showamachi,Maebashi-shi,Gunma,371-8511,JAPAN
TEL
+81-27-220-8532
Homepage URL
daisukekazama@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Medical Research Ethics Review Committee for Humans
Address
3-39-22,Showamachi,Maebashi-shi,Gunma,371-8511,JAPAN
Tel
+81272208740
ciru-hitotaisho-irb@ml.gunma-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
| 2024 | Year | 05 | 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
174
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
| 2023 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study using survey questionnaire
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061813
