Effect of an App-based Intervention on Air Pollution in COPD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: app+smartband+education.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of an Educational Intervention and an App-based Outdoor Air Pollution Alert System on Reducing Exacerbations in COPD Patients
Overview
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.
Detailed description
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.
Interventions
- Combination product app+smartband+education
Intervention: Behavioral: Health education Device: AirVisual App Device: Amazfit Band 5
Primary outcome measures
- Number of COPD exacerbations [Time frame: From baseline to 6 months]
Secondary outcome measures (7)
- Change in health-related quality of life [Time frame: Baseline and 6 months]
- Change in Physical Activity Level [Time frame: Baseline to 6 months]
- Change in BODE Index Score [Time frame: Baseline and 6 months]
- Change in Blood Pressure [Time frame: Baseline and 6 months]
- Change in Lipid profile [Time frame: Baseline and 6 months]
- Healthcare Resource Use [Time frame: 12 months before and 6 months after the intervention]
- Change in HbA1c [Time frame: Baseline and 6 months]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Unidad de Investigación de AP de Salamanca — Salamanca
Publications
- 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
Identifiers
NCT: NCT07074093 · GRS 2519/B/22