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Evaluation Study of an Influenza Care System Incorporating Self-Testing and Telemedicine

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 - iFLUTE Study: Influenza Feasibility study on self-testing and telemedicine

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059423
Enrollment
250
Registered
2025-10-15
Start date
2025-10-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Interventions

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-adminis

Sponsors

Hamamtsu University School of Medecine
Lead Sponsor
Hamamatsu Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Total medical cost per complete episode of influenza care, compared between the telemedicine and in-person groups.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactYasuhisa Tajima

Hamamtsu University School of Medecine Community Health & Preventive Medicine

online_kansensho@hmedc.or.jp080-1289-7121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026