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

Maastricht University0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•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.

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