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Pilot Intervention to Prevent Complications of Acute Respiratory Infections in Primary Care

Study acronym: AIRE-Pilot
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Study completion date: Oct 20, 2026 to Oct 30, 2026
    • Start date changed from estimate of Aug 20, 2026 to Sep 9, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute respiratory infections are common reasons for seeking primary care. Most people recover at home, but some older adults may develop respiratory complications or worsening of long-term health conditions. Clear guidance about safe activity, breathing exercises, symptom monitoring, and when to seek further care may support recovery. The goal of this pilot clinical trial is to assess whether the AIRE respiratory self-care intervention and the planned study procedures can be carried out successfully in adults aged 60 to 80 years who receive care for an acute respiratory infection in a primary care center. The pilot will inform the procedures for a larger randomized clinical trial designed to evaluate whether AIRE can prevent complications. The main questions this pilot study aims to answer are: * Can eligible participants be successfully recruited and enrolled? * Can participants complete the 14-day follow-up and daily self-report diary? * Can the AIRE intervention be delivered as planned? * Can participants assigned to AIRE follow the respiratory self-care recommendations and breathing exercises? Researchers will also explore whether participants who receive AIRE experience fewer respiratory complications within 14 days than participants who receive usual care. The pilot study is not designed to provide a definitive test of the clinical effectiveness of AIRE. Participants will be randomly assigned to one of two groups. Participants in the AIRE group will receive usual care plus a respiratory self-care session. The session will include guidance about hydration, safe daily activity, avoidance of prolonged bed rest, warning signs, and simple breathing exercises. Participants will also receive supporting educational material. Participants in the control group will receive usual care without the AIRE intervention. Participants in both groups will: * Receive telephone follow-up during the 14 days after enrollment * Record their symptoms, daily activities, and use of health services in a self-report diary * Report any new medical visits, hospital admissions, or respiratory complications The respiratory complications assessed will include sinusitis, bronchitis, pneumonia, and worsening of a long-term health condition. The findings will help researchers identify changes needed before conducting the larger clinical trial.
Trial Details
NCT Number NCT07786103
Lead Sponsor University of Chile
Conditions
(from sponsor)
Acute Respiratory Tract Infections
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov