Effect of an Educational Intervention and an App-based Outdoor Air Pollution Alert System on Reducing Exacerbations in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of COPD exacerbations
研究概览
简要总结
This study will test whether a combination of health education, a mobile app, and a smart band can help people with chronic obstructive pulmonary disease (COPD) improve their quality of life and reduce flare-ups.
Participants will be randomly assigned to one of two groups:
One group will receive health education, use a mobile app that shows real-time air quality (AirVisual), and wear a smart band that tracks activity and sleep (Amazfit Band 5).
The other group will receive standard care and advice.
All participants will complete health checks and quality-of-life questionnaires at the beginning of the study and again after 6 months.
The goal is to find out if this combination of tools helps people with COPD manage their condition better and have fewer flare-ups.
详细描述
Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that makes it hard to breathe and often gets worse over time. Many people with COPD experience flare-ups, which are periods when symptoms suddenly get worse. These flare-ups can be triggered by poor air quality and may lead to hospital visits or reduced quality of life.
This study will test a non-drug approach to help people with COPD manage their condition better. The researchers want to find out if using a combination of tools-health education, a mobile app, and a smart band-can reduce the number of flare-ups and improve quality of life.
The mobile app (AirVisual) provides real-time information about outdoor air quality, which may help participants avoid pollution. The smart band (Amazfit Band 5) tracks physical activity and sleep, helping users stay active and monitor their health. Participants in the intervention group will be trained on how to use both tools and receive general education about COPD management. The control group will receive standard care and advice.
A total of 150 participants will be recruited from urban health centers in Salamanca, Spain. Participants will be randomly assigned to either the intervention or control group. The study will last 6 months. All participants will have a clinical visit at the beginning and at the end of the study, where health measurements and quality-of-life questionnaires will be completed.
The goal is to learn whether this digital, non-pharmacological approach can support better daily management of COPD and lead to fewer symptom flare-ups.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18 years or older
- •Clinical diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD 2022 criteria (post-bronchodilator FEV1/FVC < 0.70)
- •Receiving care at urban primary care centers in Salamanca, Spain
- •Able to use a smartphone (independently or with minimal assistance)
- •Able and willing to provide written informed consent
排除标准
- •Diagnosis of a respiratory disease other than COPD (e.g., asthma, interstitial lung disease)
- •Moderate to severe cognitive impairment
- •Significant physical limitation that prevents participation in physical activity (e.g., NYHA Class III or IV heart failure, musculoskeletal conditions limiting walking)
- •Advanced kidney or liver disease
- •Severe mental illness or terminal condition
- •Participation in another clinical trial
- •Inability to use the mobile phone or smart band due to physical or technological limitations
- •Plans to relocate to another city within 12 months of study start
研究组 & 干预措施
Combined Intervention
Participants will receive:
COPD health education
Training on and use of the AirVisual mobile app (real-time air quality info)
Use of the Amazfit Band 5 (smart band to monitor activity and sleep)
Usual COPD care
干预措施: app+smartband+education (Combination Product)
Standard Care
Participants will receive:
Usual COPD care and advice as per standard guidelines
结局指标
主要结局
Number of COPD exacerbations
时间窗: From baseline to 6 months
Number of moderate or severe exacerbations, defined as worsening of respiratory symptoms requiring systemic corticosteroids, antibiotics, or hospitalization.
Number of COPD exacerbations
时间窗: From baseline to 6 months
Number of moderate or severe exacerbations, defined as worsening of respiratory symptoms requiring systemic corticosteroids, antibiotics, or hospitalization.
次要结局
- Change in health-related quality of life(Baseline and 6 months)
- Change in Physical Activity Level(Baseline to 6 months)
- Change in BODE Index Score(Baseline and 6 months)
- Change in Blood Pressure(Baseline and 6 months)
- Change in Lipid profile(Baseline and 6 months)
- Healthcare Resource Use(12 months before and 6 months after the intervention)
- Change in HbA1c(Baseline and 6 months)
- Change in health-related quality of life(Baseline and 6 months)
- Change in Physical Activity Level(Baseline to 6 months)
- Change in BODE Index Score(Baseline and 6 months)
- Change in Blood Pressure(Baseline and 6 months)
- Change in Lipid profile(Baseline and 6 months)
- Healthcare Resource Use(12 months before and 6 months after the intervention)
- Change in HbA1c(Baseline and 6 months)