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

Maastricht University0 sites150 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational non invasive

Sponsor

•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.

•\- 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.