Effect of an App-based Intervention on Air Pollution in COPD Patients

Официальное название

Effect of an Educational Intervention and an App-based Outdoor Air Pollution Alert System on Reducing Exacerbations in COPD Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт app+smartband+education
  Intervention: Behavioral: Health education Device: AirVisual App Device: Amazfit Band 5

Первичные конечные точки

• Number of COPD exacerbations [Срок оценки: From baseline to 6 months]

Вторичные конечные точки (7)

• Change in health-related quality of life [Срок оценки: Baseline and 6 months]
• Change in Physical Activity Level [Срок оценки: Baseline to 6 months]
• Change in BODE Index Score [Срок оценки: Baseline and 6 months]
• Change in Blood Pressure [Срок оценки: Baseline and 6 months]
• Change in Lipid profile [Срок оценки: Baseline and 6 months]
• Healthcare Resource Use [Срок оценки: 12 months before and 6 months after the intervention]
• Change in HbA1c [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Unidad de Investigación de AP de Salamanca — Salamanca

Публикации

• Vicente-Garcia T, Maderuelo-Fernandez JA, Marcos-Romero I, Herrero-Hernandez B, Conde-Martin S, Rodriguez-Sanchez E, Gomez-Marcos MA, Garcia-Ortiz L, Lugones-Sanchez C. The effect of an educational intervention and an app-based outdoor air pollution alert system in reducing exacerbations in patients with COPD. BMC Prim Care. 2025 Dec 1;27(1):4. doi: 10.1186/s12875-025-03109-0. PMID 41327038

Идентификаторы

NCT: NCT07074093 · GRS 2519/B/22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗