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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373070
Other study ID # 2020-00707
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2021
Est. completion date May 30, 2022

Study information

Verified date November 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to investigate the effects of a telemonitoring and chatbot-based application of "Living well with COPD" (CAir) on health-related quality-of-life in patients with COPD.


Description:

The disease management programme "Living well with COPD" was developed to relieve symptoms and prevent exacerbations. It covers a disease self-management approach, educational topics, lifestyle coaching and physical activity advice. Future implications should aim to make the intervention easily accessible for a broad spectrum of patients at scalable costs. Patients need an engaging communication platform which can inform, coach and even listen in between medical visits. The inclusion of a chatbot agent may provide this tailored feedback. The investogator's aim is to investigate the effects of a telemonitoring and chatbot-based application of "Living well with COPD" on health-related quality-of-life in patients with COPD.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: • Diagnosed COPD according to GOLD-guidelines Exclusion Criteria: - Physical or intellectual impairment precluding informed consent or protocol adherence - Non-German speaking - Acute or recent (within the last 6 weeks) exacerbation of COPD - Attending a pulmonary rehabilitation program within the last 3 months - Pregnant patients

Study Design


Intervention

Combination Product:
CAir
The CAir desk is a custom-built home disease monitoring device. The device consists of a smartphone (A320 [2017], Samsung Group, Seoul, Korea), home spirometer (Air Next Spirometer, NuvoAir, Stockholm, Sweden), physical activity tracker (Charge 3, Fitbit Inc., San Francisco CA, USA), and an air-quality monitor (Foobot, Airboxlab, Esch sur Alzette, Luxembourg). The components of the CAir desk are CE-certified.

Locations

Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health-related quality-of-life (HrQoL) St. George Respiratory Questionnaire (SGRQ). Scoring: Scores range from 0 to 100, with higher scores indicating more limitations. 3 months
Secondary Symptom burden COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms. 3 months
Secondary Spirometry Forced expiratory volume in one second (FEV1) in liters and percent predicted. 3 months
Secondary Spirometry Forced vital capacity (FVC) in liters and percent predicted. 3 months
Secondary Accelerometry Daily step count (number of steps) 3 months
Secondary Functional exercise capacity Six-minute walk test (6MWT) in meters walked. 3 months
Secondary Functional exercise capacity One-minute sit-to-stand test (1MSTS) in repetitions performed. 3 months
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