Telemonitoring for Asthma and COPD Through voICe AnalysiS: the TACTICAS study

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

18 years or older
- Physician diagnosed asthma or COPD: COPD is defined as subjects with an FEV1/FVC ratio of < 0.7 after bronchodilation. Asthma is defined as subjects with increased bronchial hyperreactivity measured with histamine provocation testing or subjects with a reversibility on spirometry. Reversibility is defined as a FEV1 or FVC response after bronchodilation of > 12% and > 200ml.
- 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

- Exacerbation of asthma or COPD within 8 weeks of inclusion into the study
- Chronic respiratory insufficiency, defined as a resting pO2 < 8.0 kPa or pCO2 > 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 dyspnea measurement as gold standard.

Secondary Outcome Measures

Name	Time	Method
? To investigate if the digital dyspnoea fingerprint correlates with asthma and COPD severity.<br>? To investigate if the digital dyspnoea fingerprint in asthma and COPD correlates with quality of life.<br>? To investigate if the digital dyspnoea fingerprint in asthma and COPD correlates with physical activity.<br>? To investigate if the digital dyspnoea fingerprint in asthma and COPD correlates with exacerbation occurrence.<br>? To develop a patient interface consisting of a chatbot smartphone application plus wearable to objectively measure symptoms in an ecological momentary assessment.<br>? To develop a clinician dashboard that provides meaningful insight into the generated longitudinal patient data.<br>? To test feasibility and evaluate the system in a real-world outpatient care scenario with COPD and asthma patients.