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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.

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.

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
+1 more other outcomes

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 InterventionBehavioral

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age60 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Other Outcomes (4)

Study Arms (2)

AIRE Comprehensive Respiratory Self-Care Intervention

Usual care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Other Outcomes (4)

Study Arms (2)

AIRE Comprehensive Respiratory Self-Care Intervention

Usual care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations