UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052243 |
|---|---|
| Receipt number | R000057959 |
| Scientific Title | Development of a training program for nursery school nurses to improve their ability to respond to children with food allergies |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2023/09/19 16:22:32 |
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Basic information
Public title
Development of a training program for nursery school nurses to improve their ability to respond to children with food allergies
Acronym
Development of a training program to improve the ability of nursery schools to respond to children with food allergies
Scientific Title
Development of a training program for nursery school nurses to improve their ability to respond to children with food allergies
Scientific Title:Acronym
Training program development
Region
| Japan |
Condition
Condition
None (nursery school nurse)
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a training program for nursery nurses to improve nurseries' ability to deal with children with food allergies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Capabilities of nurses who have attended training sessions (knowledge, skills, cooperation among staff, commissioned doctors/family doctors, medical institutions/related organizations, methods of holding study sessions, and results of exchange and consultation among nurses at day-care centers).
2. Ability of day-care centers to respond to children with food allergies (ability to cope with emergencies, ability to build partnerships within and outside the day-care centers)
Key secondary outcomes
Participants' evaluation of training 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
| Other |
Interventions/Control_1
training program
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Training program version 1
Inclusion criteria
Among the daycare center staff members, the daycare center nurses who met all of the following criteria were the participants of the study
Those who work in the Utsunomiya or the Prefectural health and medical care zone
Those who are permitted to participate in the study by the head of the daycare center
Those who have a personal computer or tablet and internet connection at home
Those who are expected to be capable of participating in the three-month training program entirely and
Those who are permitted to hold study meetings in the daycare center after the training program by the head of the daycare center.
Heads of daycare centers (or chief childcare workers)
Those who are willing to let nursery center nurses participate in the training program and
Those who can cooperate in an interview survey after the training program.
Childcare workers
Those who participated in a study meeting held in the daycare center by a nursery center nurse who attended this training program and
Those who can cooperate in a questionnaire survey after the study meeting.
Key exclusion criteria
Assistant nurses
Target sample size
528
Research contact person
Name of lead principal investigator
| 1st name | Izimi |
| Middle name | |
| Last name | Kohara |
Organization
School of Nursing, Jichi Medical University
Division name
Fundamental nursing
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture
TEL
0285-44-2111
ikohara@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Tamamura |
Organization
Graduate School of Nursing, Jichi Medical University
Division name
Doctoral Course, Graduate School of Nursing
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture
TEL
0285-44-2111
Homepage URL
dn1901@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Nursing, Jichi Medical University
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
Bioethics Committee for Medical Research, Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture
Tel
0285-58-8933
rinri@jichi.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
| 2023 | Year | 09 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | 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
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057959
