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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Participant Recruitment Rate
时间窗: Baseline
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.
Completion of 14-Day Follow-Up
时间窗: From enrollment to 14 days after enrollment
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.
Completion of the Daily Self-Report Diary
时间窗: Daily, from enrollment to 14 days after enrollment
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.
次要结局
- Successful Completion of Scheduled Telephone Contacts(From enrollment to 14 days after enrollment)
- 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 Delivery of the AIRE Intervention(Day 1)