UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062242 |
|---|---|
| Receipt number | R000071223 |
| Scientific Title | An Examination of the Construct of Caregivers,Self-Efficacy for Outings Accompanied by Children Requiring Medical Care and the Development of a Draft Version of the, Self-Efficacy Scale for Outings Accompanied by Children Requiring Medical Care. |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/15 08:10:24 |
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Basic information
Public title
This study aims to identify the factors that influence caregivers,confidence in their ability to manage outings with children requiring medical care and to develop a questionnaire to assess this confidence.
Acronym
Study on the Questionnaire for Outings with Children Requiring Medical Care
Scientific Title
An Examination of the Construct of Caregivers,Self-Efficacy for Outings Accompanied by Children Requiring Medical Care and the Development of a Draft Version of the, Self-Efficacy Scale for Outings Accompanied by Children Requiring Medical Care.
Scientific Title:Acronym
Self-Efficacy for Outings with Children Requiring Medical Care
Region
| Japan |
Condition
Condition
Primary caregivers of children requiring medical care / Healthcare and support professionals involved in the care of children requiring medical care
Classification by specialty
| Pediatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the construct of caregivers, self-efficacy for outings accompanied by children requiring medical care and to develop a draft version of the Self-Efficacy Scale for Outings Accompanied by Children Requiring Medical Care.
Basic objectives2
Others
Basic objectives -Others
Scale development [examination of the construct and development of a draft scale]
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data obtained from semi-structured interviews with caregivers and professionals will be analyzed using content analysis to identify the categories and subcategories that constitute caregivers, self-efficacy for outings accompanied by children requiring medical care. Based on the extracted constructs, an initial pool of scale items will be developed. The content validity of these items will then be evaluated by an expert panel, followed by cognitive interviews with caregivers, to develop a draft version of the Self-Efficacy Scale for Outings Accompanied by Children Requiring Medical Care.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary caregivers of children requiring medical care who have experience preparing for, making decisions about, accompanying, or considering or foregoing outings with their child, as well as healthcare or other professionals who have experience supporting outings, overnight stays, hospital discharge, home-based care, mobility and positioning, medical device management, family education, or coordination of community resources for children requiring medical care. Participants must be able to participate in an interview conducted in Japanese and provide written informed consent to participate in the study.
Key exclusion criteria
Individuals whose own condition or the condition of the child requiring medical care is unstable at the time of the interview, such that participation in the study may impose an excessive burden; individuals who have difficulty understanding the study or communicating during the interview; and individuals whom the principal investigator judges to be unsuitable for participation for any other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasutsugu |
| Middle name | |
| Last name | Asakawa |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
029-840-2207
asakaway@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Minenao |
| Middle name | |
| Last name | Sasahara |
Organization
Graduate School of Ibaraki Prefectural University of Health Sciences
Division name
Doctoral Program, Graduate School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
090-6540-3375
Homepage URL
45170055@ipu.ac.jp
Sponsor or person
Institute
Department of Physical Therapy, School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy, School 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
Research Ethics Committee, Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
Tel
029-840-2107
iimurasa@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
| 2026 | Year | 07 | Month | 15 | 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
| 2026 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective qualitative descriptive observational study and scale item development study. From September 2026 to April 2027, primary caregivers of children requiring medical care who are receiving inpatient or outpatient care at the Ibaraki Prefectural University of Health Sciences Hospital, as well as healthcare and other professionals affiliated with the Ibaraki Prefectural University of Health Sciences or its affiliated hospital who have experience supporting outings, overnight stays, hospital discharge, home-based care, or related services for children requiring medical care, will be purposively recruited.
Semi-structured interviews will be conducted with caregivers and professionals to explore their experiences with outings, situations that make outings difficult, conditions under which caregivers perceive themselves as capable of managing outings, and the support and environmental resources considered necessary. Outing frequency will not be used as an eligibility criterion, and participants with a range of outing experiences will be included.
Interview recordings will be transcribed verbatim and analyzed using content analysis based on Berelson's approach to identify the constructs of caregivers' self-efficacy for outings accompanied by children requiring medical care. Based on the identified constructs, an initial pool of scale items will be developed. The content validity of the items will then be evaluated by an expert panel, followed by cognitive interviews with caregivers, to develop a draft version of the scale.
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071223
