UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049051 |
|---|---|
| Receipt number | R000055881 |
| Scientific Title | Development of psychoeducational program for parents of a child with food allergy |
| Date of disclosure of the study information | 2022/09/28 |
| Last modified on | 2022/09/28 13:42:11 |
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Basic information
Public title
Development of psychoeducational program for parents of a child with food allergy
Acronym
Development of psychoeducational program for parents of a child with food allergy
Scientific Title
Development of psychoeducational program for parents of a child with food allergy
Scientific Title:Acronym
Development of psychoeducational program for parents of a child with food allergy
Region
| Japan |
Condition
Condition
Parents of a child with food allergy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To development and evaluate the efficacy of psychoeducational program for parents of a child with food allergy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in knowledges about food allergy and anxiety of parents of a child with food allergy before and after the psychoeducational program
Key secondary outcomes
Evaluate the psychoeducational 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 | Maneuver |
Interventions/Control_1
The psychoeducational program contains the lecture and peer meeting(group therapy). One group has capacity of 5-8 persons. The program are held online session or face to face session. We ask parents participated in the program to fill out several questionnaires before and after the program to evaluate the efficacy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents of a child with food allergy
Key exclusion criteria
nothing
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | REIKO |
| Middle name | |
| Last name | NAKAJIMA |
Organization
Toyohashi Sozo University
Division name
School of Health Sciences Department of Nursing
Zip code
440-8511
Address
20-1 Matsushita,Ushikawa-cho,Toyohashi-City,Aichi
TEL
05020172295
r-nakajima@sozo.ac.jp
Public contact
Name of contact person
| 1st name | REIKO |
| Middle name | |
| Last name | NAKAJIMA |
Organization
Toyohashi Sozo University
Division name
School of Health Sciences Department of Nursing
Zip code
440-8511
Address
20-1 Matsushita,Ushikawa-cho,Toyohashi-City,Aichi
TEL
05020172295
Homepage URL
r-nakajima@sozo.ac.jp
Sponsor or person
Institute
Toyohashi Sozo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyohashi Sozo University Research Ethics Committee
Address
20-1 Matsushita,Ushikawa-cho,Toyohashi-City,Aichi
Tel
05020172295
r-nakajima@sozo.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 | 09 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055881
