COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Air Quality, Mobile Health (mHealth), Digital Intervention, Smart Band / Wearable Device
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.
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_PRODUCTapp+smartband+education
Intervention: Behavioral: Health education Device: AirVisual App Device: Amazfit Band 5
Sponsors
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of COPD exacerbations | From baseline to 6 months | Number of moderate or severe exacerbations, defined as worsening of respiratory symptoms requiring systemic corticosteroids, antibiotics, or hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity Level | Baseline to 6 months | Global Physical Activity Questionnaire (GPAQ) in both groups; Step count and kilocalories burned (intervention group only, via Amazfit Band 5) |
| Change in health-related quality of life | Baseline and 6 months | The Saint George's Respiratory Questionnaire assesses symptoms, activity limitation, and disease impact. Scores range from 0 (best health) to 100 (worst health). |
| Change in BODE Index Score | Baseline and 6 months | 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%) |
| Change in Blood Pressure | Baseline and 6 months | OMROM M10 blood pressure monitor (average of last 2 out of 3 measurements). SBP and DBP. Units: mmHg |
| Change in Lipid profile | Baseline and 6 months | Total cholesterol, HDL, LDL, and triglycerides. Units: mg/dL |
| Healthcare Resource Use | 12 months before and 6 months after the intervention | Number of primary care visits, emergency visits, hospital admissions, use of antibiotics, inhalers, and systemic corticosteroids (from Castilla y León EHR system) |
| Change in HbA1c | Baseline and 6 months | A blood test that shows your average level of blood glucose over the past two to three months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Height | Baseline and 6 months | Measured using a calibrated stadiometer. Units: m |
| Frailty (for participants aged >65 years) | Baseline and 6 months | Fried Frailty Criteria is a clinical scale used to assess frailty in older adults based on five components. Minimum and Maximum Values: 0-5. A higher score indicates greater frailty (0: Non-frail; 1-2: Pre-frail; 3-5: Frail) |
| ICT Usability and Adherence (Intervention Group only) | At 6 months | mHealth App Usability Questionnaire (MAUQ) to assess the usability of the mobile health app. Contains multiple items rated on a 7-point Likert scale. Scores ranged from 20 to 140, and higher scores indicate better outcomes (greater usability and acceptance of the mobile app). |
| Smoking status | Baseline and 6 months | Participants will be classified into three categories based on current and past smoking behaviour: Current smoker, Former smoker, Never smoker. |
| Body weight | Baseline and 6 months | Measured with an electronic scale. Units: Kg |
| Sex | Baseline | Sex will be recorded as reported by the participant or as documented in the medical record. Categories: Male, Female |
Countries
Spain
Outcome results
None listed