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

NCT07786103 | Not Yet Recruiting

• 1 other identifier: AIRE422026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Tract Infections

Keywords

Acute respiratory tract infections; Respiratory self-care; Older adults; Breathing exercises; Prevention of complications; Pilot study

Outcome Measures

Primary Outcomes (3)

• Participant Recruitment Rate

  The proportion of eligible individuals who provide informed consent and are enrolled in the study. The recruitment rate will be calculated as the number of participants enrolled divided by the total number of eligible individuals invited to participate, multiplied by 100. The number of individuals screened, eligible, invited, and enrolled will be recorded. Reasons for exclusion, refusal, or non-enrollment will also be documented and summarized by category.

  Baseline

• Completion of 14-Day Follow-Up

  The proportion of enrolled participants who complete the final study assessment on day 14. A participant will be considered to have completed follow-up if information on symptoms, healthcare use, and possible respiratory complications is available through the day 14 telephone assessment or clinical record review. The measure will be reported as the number of participants who complete follow-up divided by the total number enrolled, multiplied by 100.

  From enrollment to 14 days after enrollment

• Completion of the Daily Self-Report Diary

  The proportion of expected daily self-report diary entries completed by participants during the 14-day follow-up period. The diary records symptoms, daily activity, ability to perform usual activities, healthcare use, and, for participants assigned to AIRE, performance of breathing exercises. Completion will be calculated as the number of diary entries submitted divided by the total number of expected entries, multiplied by 100.

  Daily, from enrollment to 14 days after enrollment

Secondary Outcomes (4)

• Adherence to AIRE Breathing Exercises

  Daily, from enrollment through day 10 after enrollment

• Incidence of Respiratory Complications Within 14 Days

  From enrollment to 14 days after enrollment

• Successful Completion of Scheduled Telephone Contacts

  From enrollment to 14 days after enrollment

• Successful Delivery of the AIRE Intervention

  Day 1

Other Outcomes (4)

• Duration of the Initial AIRE Intervention Session

  Day 1

• Frequency of Operational Problems During Study Implementation

  From participant screening to 14 days after enrollment

• Acceptability of the AIRE Intervention

  From the initial intervention session to 14 days after enrollment

Study Arms (2)

AIRE Comprehensive Respiratory Self-Care Intervention

EXPERIMENTAL

Participants assigned to this arm will receive the AIRE intervention in addition to usual care for acute respiratory infections. The intervention includes respiratory self-care education, guidance to support safe recovery at home, and breathing exercise instruction. Participants will complete the same follow-up and outcome assessments as the control group.

Behavioral: AIRE Comprehensive Respiratory Self-Care Intervention

Usual care

NO INTERVENTION

Participants assigned to this arm will receive usual care for acute respiratory infections according to standard practice at the primary care center, without the AIRE self-care education or breathing exercise instruction. They will undergo the same study follow-up and outcome assessments as participants in the experimental group.

Interventions

AIRE Comprehensive Respiratory Self-Care Intervention BEHAVIORAL

AIRE is a multicomponent respiratory self-care intervention delivered individually by a trained respiratory physical therapist. Participants receive a structured education session lasting approximately 10 minutes. The session covers hydration, warning signs, safe daily activity, and recommendations to avoid prolonged bed rest during recovery. Participants are taught breathing control followed by slow exhalation through pursed lips. Each breathing exercise session lasts approximately 5 to 10 minutes and is performed twice daily for 5 to 10 consecutive days, according to symptoms and tolerance. Participants are advised to stop the exercises if they experience dizziness, marked shortness of breath, chest pain, or worsening symptoms. Printed or audiovisual materials reinforce the recommendations and exercise instructions.

AIRE Comprehensive Respiratory Self-Care Intervention

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

CESFAM Dr. Agustín Cruz Melo

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Central Study Contacts

Manuel A Rain, MSc

CONTACT

56 976345940; manuel.rain@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This pilot study is open-label because its primary purpose is to assess recruitment, intervention delivery, adherence, follow-up, and operational feasibility. Participants and the respiratory physical therapist delivering the intervention will be aware of group allocation. Blinded outcome adjudication is planned for the subsequent full-scale randomized controlled trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 25, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-07

Locations

CL (1)