asthma COPD
Conditions
Interventions
None listed
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older - Physician diagnosed asthma or COPD: - Willingness and demonstration of ability to use a smartphone and fitness watch and to allow remote monitoring of vital signs. - Able to understand, read and write Dutch language
Exclusion criteria
Exclusion criteria: - Exacerbation of asthma or COPD within 8 weeks of inclusion into the study - Chronic respiratory insufficiency, defined as a resting pO2 6.5 kPa, measured at sea level - Co-morbidities that interfere with the registration or interpretation of symptoms, physical activity or quality of life, such as severe heart failure, interstitial lung diseases, or neuromuscular disorders. - Persons who are dependent on others for activities of daily living. - Persons who use a wheelchair or walker. - Active malignancy. - Expected life-expectancy less than 1 year. - Investigator*s uncertainty about the willingness or ability of the patient to comply with the protocol requirements. - Participation in another study involving (non)-investigational products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective To derive a digital fingerprint of dyspnoea in asthma and COPD by combining speech analysis as well as features extracted from spoken dialogue with daily dyspnoea measurement as gold standard. Endpoints for primary objective: Voice analysis: syllables per breath group during standardized free language self-report Daily Dyspnoea burden: E-RS score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate if the digital dyspnoea fingerprint correlates with asthma and COPD severity Voice analysis: syllables per breath group and other acoustic speech measurements Disease severity: FEV1 (COPD and asthma), exacerbation burden in the previous year 2. To investigate if the digital dyspnoea fingerprint in asthma and COPD correlates with quality of life. Voice analysis: syllables per breath group and others acoustic speech measurements QoL: CAT (COPD), ACT (asthma) 3. To investigate if the digital dyspnoea fingerprint in asthma and COPD correlates with physical activity. Voice analysis: syllables per breath group and other acoustic speech measurements Physical activity: daily step count, 24-h heart rate, VAS score during physical activity 4. To investigate if the digital dyspnoea fingerprint in asthma and COPD correlates with exacerbation occurrence. Voice analysis: syllables per breath group and other acoustic speech measurements Exacerbations: EXACT Score 5. To develop a patient interface consisting of a chatbot smartphone application plus wearable to objectively measure symptoms in an ecological momentary assessment. N/A 6. To develop a clinician dashboard that provides meaningful insight into the generated longitudinal patient data. 7. To test feasibility and evaluate the system in a real-world outpatient care scenario with COPD and Asthma patients. | — |
Countries
Netherlands
Outcome results
None listed