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

NCT07074093 | Enrolling By Invitation

• 1 other identifier: GRS 2519/B/22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Air Quality; Mobile Health (mHealth); Digital Intervention; Smart Band / Wearable Device

Outcome Measures

Primary Outcomes (1)

• Number of COPD exacerbations

  Number of moderate or severe exacerbations, defined as worsening of respiratory symptoms requiring systemic corticosteroids, antibiotics, or hospitalization.

  From baseline to 6 months

Secondary Outcomes (7)

• 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

Other Outcomes (6)

• Sex

  Baseline

• Body weight

  Baseline and 6 months

• Height

  Baseline and 6 months

Study Arms (2)

Combined Intervention

EXPERIMENTAL

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

Combination Product: app+smartband+education

Standard Care

NO INTERVENTION

Participants will receive: Usual COPD care and advice as per standard guidelines

Interventions

app+smartband+education COMBINATION_PRODUCT

Intervention: Behavioral: Health education Device: AirVisual App Device: Amazfit Band 5

Combined Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion y Formacion en Ciencias de la Salud: lead

Study Sites (1)

Unidad de Investigación de AP de Salamanca

Salamanca, Salamanca, 37004, Spain

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 20, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The protocol will be published by the end of 2025. De-identified participant data will be made available by the end of 2026, following the main results publication.
• Access Criteria: Access will be granted to researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to the corresponding author. Requestors will need to sign a data access agreement. Final access mechanism (repository or institutional platform) will be detailed upon publication.

Locations

ES (1)