UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043070 |
|---|---|
| Receipt number | 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 22:37:04 |
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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
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
takuois@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031747
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
