COPD (Chronic Obstructive Pulmonary Disease)NCT07074093
Effect of an App-based Intervention on Air Pollution in COPD Patients
A study testing app+smartband+education in people with COPD (Chronic Obstructive Pulmonary Disease), run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- app+smartband+education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jun 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Unidad de Investigación de AP de Salamanca
Salamanca, Salamanca, 37004
About this study
Official title: Effect of an Educational Intervention and an App-based Outdoor Air Pollution Alert System on Reducing Exacerbations in COPD Patients
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:
Read more
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.
Read the 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.
- Being tested
- app+smartband+education
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Air Quality, Mobile Health (mHealth), Digital Intervention, Smart Band / Wearable Device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app+smartband+educationCombination product
Intervention:
Behavioral: Health education
Device: AirVisual App
Device: Amazfit Band 5
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: app+smartband+education |
| Standard Care | No intervention | Participants will receive: Usual COPD care and advice as per standard guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of COPD exacerbations
Number of moderate or severe exacerbations, defined as worsening of respiratory symptoms requiring systemic corticosteroids, antibiotics, or hospitalization.
Measured: From baseline to 6 months
Secondary outcomes (7)
Change in health-related quality of life
The Saint George's Respiratory Questionnaire assesses symptoms, activity limitation, and disease impact. Scores range from 0 (best health) to 100 (worst health).
Measured: Baseline and 6 months
Change in Physical Activity Level
Global Physical Activity Questionnaire (GPAQ) in both groups; Step count and kilocalories burned (intervention group only, via Amazfit Band 5)
Measured: Baseline to 6 months
Change in BODE Index Score
It stands for Body mass index, Obstruction (FEV1), Dyspnea (mMRC), and Exercise capacity (6-minute walk test). Its value ranges from 0 to 10 points, where 10 indicates maximum mortality risk. This score is divided into four quartiles to determine survival rates: quartile 1 (0-2 points - 82%), quartile 2 (3-4 points - 69%), quartile 3 (5-6 points - 60%), quartile 4 (7-10 points - 25%)
Measured: Baseline and 6 months
Change in Blood Pressure
OMROM M10 blood pressure monitor (average of last 2 out of 3 measurements). SBP and DBP. Units: mmHg
Measured: Baseline and 6 months
Change in Lipid profile
Total cholesterol, HDL, LDL, and triglycerides. Units: mg/dL
Measured: Baseline and 6 months
Healthcare Resource Use
Number of primary care visits, emergency visits, hospital admissions, use of antibiotics, inhalers, and systemic corticosteroids (from Castilla y León EHR system)
Measured: 12 months before and 6 months after the intervention
Change in HbA1c
A blood test that shows your average level of blood glucose over the past two to three months.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start16 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074093
- Sponsor's protocol ID
- GRS 2519/B/22
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PD Description: De-identified individual participant data that underlie the results reported in publications will be shared, including baseline characteristics, outcome measures, and limited subsets of laboratory and device-recorded data.
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.
PubMed 41327038
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Intervention and an App-based Outdoor Air Pollution Alert System on Reducing Exacerbations in COPD Patients
- ClinicalTrials.gov ID
- NCT07074093
- Acronym / sponsor ID
- GRS 2519/B/22
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Air Quality, Mobile Health (mHealth), Digital Intervention, Smart Band / Wearable Device
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention | Experimental | Combination Product: app+smartband+educationParticipants 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 |
| Standard Care | No intervention | –Participants will receive: Usual COPD care and advice as per standard guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| app+smartband+educationIntervention: Behavioral: Health education Device: AirVisual App Device: Amazfit Band 5 | Combination product | Combined Intervention |
Primary outcome
Number of COPD exacerbations
Time frame: From baseline to 6 months
Number of moderate or severe exacerbations, defined as worsening of respiratory symptoms requiring systemic corticosteroids, antibiotics, or hospitalization.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 41327038Vicente-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.
- Individual participant dataSharing planned: Yes. PD Description: De-identified individual participant data that underlie the results reported in publications will be shared, including baseline characteristics, outcome measures, and limited subsets of laboratory and device-recorded data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing app+smartband+education in people with COPD (Chronic Obstructive Pulmonary Disease), run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of COPD exacerbations (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07074093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.