UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049939 |
|---|---|
| Receipt number | R000056877 |
| Scientific Title | Evaluation of the Effectiveness of a Smartphone Application for Hay Fever Treatment Assistance in Improving of Subjective Symptoms of Hay Fever: A Prospective, Randomized, Controlled Study. |
| Date of disclosure of the study information | 2023/01/14 |
| Last modified on | 2023/07/05 14:11:44 |
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Basic information
Public title
Evaluation of the effectiveness of a smartphone app for hay fever treatment assistance in improving subjective symptoms of hay fever.
Acronym
Evaluation of the effectiveness of a smartphone app for hay fever treatment assistance in improving hay fever symptoms.
Scientific Title
Evaluation of the Effectiveness of a Smartphone Application for Hay Fever Treatment Assistance in Improving of Subjective Symptoms of Hay Fever: A Prospective, Randomized, Controlled Study.
Scientific Title:Acronym
Evaluation of the Effectiveness of a Smartphone App for Hay Fever Treatment Assistance in Improving of Subjective Symptoms of Hay Fever.
Region
| Japan |
Condition
Condition
Hay fever
Classification by specialty
| Ophthalmology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the effectiveness of a smartphone application (ALA01) as a hay fever treatment assistance will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The following items at 4 weeks after the inclusion time point (Day 0)
Hay fever subjective symptom assessment: Nasal symptom score (NSS), Non-nasal symptom score (NNSS), Total symptom score (TSS), and Allergic Conjunctival Quality of Life Questionnaire (JACQLQ) Domain II score2
Key secondary outcomes
The following items at 4 weeks after the inclusion time point (Day 0)
(1) Basic information on research subjects: age, sex, diagnosis, duration of disease, treatment details (drugs used, duration of treatment)
(2) Allergy test results
(3) Medication adherence assessment: Medication adherence scale (MMAS-8)
(4) Medication record
(5) Viewing status of educational contents in the application
(6) Operability evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use ALA01 in addition to prescribed hay fever medications.
Interventions/Control_2
Use only prescribed hay fever medications.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with NSS score between 3 and 10 and NNSS score between 3 and 8 on Day 0.
(2) Patients who can understand and agree to the consent form
(3) Patients who can operate a smart phone
(4) Patients who are 20 years of age or older
Key exclusion criteria
(1) Those who are deemed inappropriate as research subjects by the principal investigator
(2) Those who could not give their consent
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University
Division name
Graduate School of Medicine, Department of Ophthalmology
Zip code
113-8421
Address
2-1-1 Hongo, Building A, 6th floor, Ophthalmology Department, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1228
tinoma@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University
Division name
Graduate School of Medicine, Department of Ophthalmology
Zip code
113-8421
Address
2-1-1 Hongo, Building A, 6th floor, Ophthalmology Department, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1228
Homepage URL
tinoma@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Independent Ethics Committee of Juntendo University Faculty of Medicine
Address
3-1-3 Hongo, Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan
Tel
03-3814-5672
jcrtc_operation@juntendo.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 | 01 | Month | 14 | 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
| 2022 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | 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 | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056877
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| Registered date | File name |
| Research case data | |
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