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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27652
Enrollment
150
Registered
2021-03-23
Start date
2021-05-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma, COPD

Interventions

none

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 18 years or older - Physician diagnosed asthma or COPD: COPD is defined as subjects with an FEV1/FVC ratio 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

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

Secondary

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

Primary

MeasureTime frame
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.

Contacts

Public ContactSami Simons

Maastricht University

sami.simons@mumc.nl0433877043

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)