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

Pilot Randomized Controlled Trial of the AIRE Comprehensive Respiratory Self-Care Intervention for Preventing Complications of Acute Respiratory Infections in Older Adults in Primary Care

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.

Inclusion Criteria:

• Adults of any sex aged 60 to 80 years.
• Clinical diagnosis of an ambulatory influenza-like illness, defined as acute-onset cough with fever or a feeling of fever, plus at least one of the following symptoms: muscle aches, sore throat, or headache. Laboratory confirmation of the causative pathogen is not required.
• Five days or less since the onset of the first symptom.
• Presence of at least one of the following chronic conditions or risk factors: hypertension, dyslipidemia, diabetes mellitus, obesity defined as a body mass index of 30 kg/m² or higher, chronic kidney disease, or current smoking.
• Regular access to and use of WhatsApp.

Exclusion Criteria:

• Need for antibiotic treatment at the initial visit because of an evident or suspected bacterial infection.
• Cognitive impairment that prevents understanding of the study or intervention.
• Cancer under active treatment.
• Physical limitations that prevent performance of the breathing exercises.
• Hospitalization for any cause within the previous 6 months.