UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059423 |
|---|---|
| Receipt number | R000066831 |
| Scientific Title | Feasibility Study on the Economic Evaluation of a Diagnostic System Combining Self-Testing and Telemedicine: An Open-Label Interventional Trial Targeting Adults Without Risk Factors for Severe Influenza |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 19:16:03 |
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Basic information
Public title
Evaluation Study of an Influenza Care System Incorporating Self-Testing and Telemedicine
Acronym
iFLUTE Study
Scientific Title
Feasibility Study on the Economic Evaluation of a Diagnostic System Combining Self-Testing and Telemedicine: An Open-Label Interventional Trial Targeting Adults Without Risk Factors for Severe Influenza
Scientific Title:Acronym
iFLUTE Study: Influenza Feasibility study on self-testing and telemedicine
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the usefulness of online (telemedicine) consultations in terms of healthcare economics and reduction of patient burden by comparing them with previously conducted face-to-face consultations among patients who develop influenza symptoms, obtain a positive result on a self-administered test, and have no risk factors for severe disease. Specifically, the primary outcome is the total medical cost incurred for a complete episode of influenza care.
Basic objectives2
Others
Basic objectives -Others
Secondary outcomes include (1) time from symptom onset to consultation, (2) psychological burden assessed by questionnaire, and (3) post-consultation clinical outcomes, in order to assess the economic impact of telemedicine and its contribution to reducing patient burden.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total medical cost per complete episode of influenza care, compared between the telemedicine and in-person groups.
Key secondary outcomes
1) Interval from symptom onset to consultation (hours).
2) Patient-reported psychological burden measured by questionnaire.
3) Clinical outcomes after the consultation (e.g., complications, re-consultation).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention name: Telemedicine for influenza following positive self-administered test
Intervention details: Among patients with influenza-like illness who obtain a positive result on a self-administered influenza rapid antigen test, care is delivered via online consultation (in place of, or prior to, in-person care) for adults without risk factors for severe disease.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Telemedicine Group
Age 18 to less than 65 years.
Residence in the pre-reorganization wards of Hamamatsu City: former Naka, Higashi, Nishi, Minami, or Kita Ward.
No risk factors for severe influenza: none of the following (pregnancy, underlying comorbidities, BMI >= 30, current smoking).
Able to perform a combined COVID-19 and influenza rapid antigen self-test after onset of influenza-like illness.
Willing to receive telemedicine during the designated hours if the self-test is positive for influenza.
Agrees to online consultation via the CLINICS app and to online medication counseling.
Has or can obtain a Hamamatsu Medical Center patient ID.
Provides written informed consent after understanding the study purpose.
Historical In-Person Group
Visited the Hamamatsu Medical Center after hours during Dec 1, 2017 - Mar 31, 2018 or Dec 1, 2018 - Mar 31, 2019.
Age 18 to less than 65 years.
Diagnosed with influenza based on a positive rapid antigen test at the index visit.
Registered address at the time of visit within the pre-reorganization wards of Hamamatsu City: former Naka, Higashi, Nishi, Minami, or Kita Ward.
No risk factors for severe influenza: none of the following (pregnancy, underlying comorbidities, BMI >= 30, current smoking).
Key exclusion criteria
Telemedicine Group
Patients meeting any of the following will be excluded:
Do not possess the devices/equipment necessary to receive telemedicine.
Despite fever or influenza-like symptoms, have strong anxiety about telemedicine and strongly prefer in-person consultation at a medical facility.
Lack an environment that ensures privacy for receiving telemedicine.
Have previously experienced major disadvantages or troubles related to telemedicine (e.g., communication failures, misdiagnosis, prescription errors).
Have plans for long-term business trips or travel, making continuous contact and follow-up during the study period difficult.
Report strong psychological stress or anxiety specifically regarding participation in the study.
Have cognitive impairment or compromised decision-making capacity such that appropriate consent/participation is deemed difficult.
Are concurrently participating in another clinical study.
Are taking antiplatelet or anticoagulant medications, or have a history of epistaxis or other bleeding disorders (due to increased bleeding risk associated with self-collected nasal specimens).
Historical In-Person Group
Patients meeting the following will be excluded:
After public disclosure via opt-out, expressed refusal to participate.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Ojima |
Organization
Hamamtsu University School of Medecine
Division name
Community Health & Preventive Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
online_kansensho@hmedc.or.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Tajima |
Organization
Hamamtsu University School of Medecine
Division name
Community Health & Preventive Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
080-1289-7121
Homepage URL
online_kansensho@hmedc.or.jp
Sponsor or person
Institute
Hamamtsu University School of Medecine
Institute
Department
Personal name
Funding Source
Organization
OTC Self-Medication Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamtsu University School of Medecine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2025 | Year | 10 | Month | 15 | 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
| 2025 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066831
