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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043070
Receipt No. R000031747
Scientific Title The study of training method on epinephrine auto-injector for patients and their caregivers with calendar.
Date of disclosure of the study information 2021/01/20
Last modified on 2021/01/20

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Basic information
Public title The study of training method on epinephrine auto-injector for patients and their caregivers with calendar.
Acronym The study of training method on epinephrine auto-injector.
Scientific Title The study of training method on epinephrine auto-injector for patients and their caregivers with calendar.
Scientific Title:Acronym The study of training method on epinephrine auto-injector.
Region
Japan

Condition
Condition anaphylaxis
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of the method to keep a hand skill of adrenaline auto-injector.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of the person who can do a certain hand skill at the time of return of adrenaline auto-injector about 1 year later
Key secondary outcomes 1. Relation between the practice number of times of the hand skill for about 1 year, the DVD watching number of times of the pharmaceutical company and a certain hand skill.
2. Relation between practiced day, the day when a DVD was watched and a certain hand skill.
3. Relation between background about patients and a guardian and a certain hand skill.

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 A day of practice and a watching day of a DVD are indicated on a calendar.
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
20 years-old >
Gender Male and Female
Key inclusion criteria Patient and the guardian which have adrenaline auto-injector with food allergy . The target of evaluation is the guardian until patient become junior high school.
Key exclusion criteria The patient who didn't agree to this research.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Oishi
Organization Kochi Medical School, Kochi University
Division name Department of pediatrics
Zip code 7838505
Address Kohasu, Oko-Cho, Nankoku. Kochi
TEL 088-880-2355
Email takuois@kochi-u.ac.jp

Public contact
Name of contact person
1st name Taku
Middle name
Last name Oishi
Organization Kochi Medical School, Kochi University
Division name Department of pediatrics
Zip code 7838505
Address Kohasu, Oko-Cho, Nankoku. Kochi
TEL 088-880-2355
Homepage URL
Email takuois@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization The Morinaga Foundation for Health & Nutrition
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kochi Medical School, Kochi University
Address Kohasu, Oko-Cho, Nankoku. Kochi
Tel 088-866-5811
Email rinri21@kochi-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
2021 Year 01 Month 20 Day

Related information
URL releasing protocol https://kochi-pediatrics.jp/wp-content/uploads/2021/01/protocol-AAI-diary.pdf
Publication of results Partially published

Result
URL related to results and publications https://kochi-pediatrics.jp/wp-content/uploads/2021/01/main-result-AAI-diary.pdf
Number of participants that the trial has enrolled 102
Results A total of 102 participants were registered. At enrollment, 82 participants who had previous Adrenaline auto-injectors (AAI) prescription history, 38 of 82 (46.3%) used correctly. Except for hold place for 5 seconds and massage, 56 of 82 (68.3%) used correctly. Ninety-seven participants could be confirmed after one year, and 81 of them (83.5%) used AAI correctly.
Results date posted
2021 Year 01 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics A total of 102 patients participated in the study. They had a median age 7.5 (5-10) years. Seventy four percent of patients had the history of anaphylaxis. Five percent of patient have ever used AAI. The experience of prescription are shown here: the first time was 19.6%. The second time was 15.7%. The third time was 14.7%. More than the third time was 50.0%. Three point nine percent of participants had the other family member who had AAI. The family history of anaphylaxis was 16.7%. Ninety three participants were the caregivers of the patients. The final study population comprised 97 participants.
Participant flow One hundred eight patients had candidacy.Six patients did not participate in this study.
Two went on to universities.Three were siblings.One was no reason. A total of 102 patients participated in the study.Five patients dropped out.Ninety-seven participants could be confirmed after one year.
Adverse events nothing
Outcome measures We aimed at evaluating the sustained effect of education about how to use AAI
after one year with AAI diary(calendar) .
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
2019 Year 09 Month 25 Day
Anticipated trial start date
2017 Year 10 Month 18 Day
Last follow-up date
2019 Year 10 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 20 Day
Last modified on
2021 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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