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CompletedNCT04806477Updated Aug 31, 2021

Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.

An interventional study of Telemedicine Consultation and Face-to-face Consultation in Respiratory Tract Infections, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a randomized study that sought to analyze the diagnostic accuracy of the telemedicine consultation of patients suspected of respiratory tract infections during COVID-19 pandemic in comparison with the face-to-face evaluation at the emergency department.

Read the detailed description

Unicentric, prospective and randomized study performed between September and November 2020 with adult patients who sought care at emergency department. The inclusion criterion was the exhibition of any tract respiratory symptom. Patients older than 65 years, with chronic heart or lung diseases or immunosuppressed were excluded. Eligible patients were randomized 1:1 for a brief telemedicine consultation, blinded to subsequent face-to-face evaluation or direct face-to-face evaluation.

02

Conditions studied

  • Respiratory Tract Infections

Keywords

  • Telemedicine
  • Respiratory Tract Infections
  • Emergency Medical Services
  • Referral and Consultation
  • COVID-19
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 98 is below the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with at least one acute symptom compatible with RTI (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) in presence or absence of symptoms related to the infection (fever ≥ 38oC, chills, sweating, myalgia) that motivated spontaneously face-to-face evaluation at the ED.

Exclusion criteria

Exclusion Criteria:

  • Patients with diagnosis of chronic respiratory diseases (chronic obstructive pulmonary disease, asthma and interstitial lung disease)
  • Patients with previous diagnosis of congestive heart failure,
  • Patients with HIV / AIDS
  • Patients with active cancer
  • Patients with type I diabetes mellitus
  • Patients in use of any immunosuppressant
  • Patients with chronic cough
  • Patiets that referral to emergency room after nursing triage.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Active comparator
    Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation

    We included adults (≥18 years of age) who had at least one acute symptom compatible with Respiratory Tract Infection (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) with or without symptoms related to the infection (fever ≥ 38oC, chills, sweating, myalgia) who have undergone telemedicine consultation before face-to-face evaluation

    Other: Telemedicine Consultation · Other: Face-to-face Consultation

  • Active comparator
    Adult patients with respiratory tract symptom - only face-to-face evaluation

    We included adults (≥18 years of age) who had at least one acute symptom compatible with Respiratory Tract Infection (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) with or without symptoms related to the infection (fever ≥ 38oC, chills, sweating, myalgia) who have undergone only face-to-face evaluation

    Other: Face-to-face Consultation

Interventions

  • OtherTelemedicine Consultation

    Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.

  • OtherFace-to-face Consultation

    Direct face-to-face evaluation (without telemedicine consultation before).

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What researchers measure

Primary outcomes

  1. Number of final evaluation ICD 10-code diagnosis.

    All institutional Emergency Department or Telemedicine assessments involve filling out the final diagnosis on an International Classification of Diseases (ICD-10)-code basis in the electronic medical record before discharge to home or admission. For aggregation of most prevalent RTI with similar pathophysiologic characteristics, three diagnostic groups were defined, based on ICD 10 codes: RTI, including COVID-19 (B34.2, B34.9, B97.2, J00, J04, J06, J11, J20, J30, J39, U07.1); PT - Acute Pharyngotonsillitis (J02-J03.9) and AS - Acute Sinusitis (J01-J01.9).

    Time frame: up to 10 months

Secondary outcomes

  1. Time of medical care

    Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.

    Time frame: up to 10 months

  2. Rate of indication for complementary exams

    Comparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation.

    Time frame: up to 10 months

  3. Type of requested exams

    Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation.

    Time frame: up to 10 months

  4. Type of Medical prescription

    Comparison of type of medical prescription after completion of the service between telemedicine and face-to-face consultation

    Time frame: up to 10 months

  5. Type of proposed destination after completion of the service

    Comparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation.

    Time frame: up to 10 months

07

Study locations

1 site
  • Hospital Israelita Abert Einstein
    São Paulo, SP 05652-900, Brazil
08

References and documents

Publications

  • Accorsi TAD, Moreira FT, Pedrotti CHS, Amicis K, Correia RFV, Morbeck RA, Medeiros FF, Souza JL Jr, Cordioli E. Telemedicine diagnosis of acute respiratory tract infection patients is not inferior to face-to-face consultation: a randomized trial. Einstein (Sao Paulo). 2022 May 27;20:eAO6800. doi: 10.31744/einstein_journal/2022AO6800. eCollection 2022. PubMed 35649057 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04806477
Lead sponsor
Hospital Israelita Albert Einstein
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Sep 1, 2020
Primary completion
Nov 1, 2020
Completion
Nov 1, 2020
Last update
Aug 31, 2021

Study contacts

Eduardo HS Cordioli, MD
study director · Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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