Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059423) titled 'Evaluation Study of an Influenza Care System Incorporating Self-Testing and Telemedicine' on Oct. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Hamamtsu University School of Medecine

Condition: Condition - Influenza Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 250

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066831

Disclaimer: Curated by HT Syndication.