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Completed

NCT Number: NCT04373070

Quality-of-Life Management for COPD Patients

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.

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Key information

Conditions

COPD Chronic Disease Chronic Respiratory Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAir

Combination Product

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.

Primary outcomes

  1. Health-related quality-of-life (HrQoL)

    Time frame: 3 months

    St. George Respiratory Questionnaire (SGRQ). Scoring: Scores range from 0 to 100, with higher scores indicating more limitations.

Secondary outcomes

  1. Symptom burden

    Time frame: 3 months

    COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms.

  2. Spirometry

    Time frame: 3 months

    Forced expiratory volume in one second (FEV1) in liters and percent predicted.

  3. Spirometry

    Time frame: 3 months

    Forced vital capacity (FVC) in liters and percent predicted.

  4. Accelerometry

    Time frame: 3 months

    Daily step count (number of steps)

  5. Functional exercise capacity

    Time frame: 3 months

    Six-minute walk test (6MWT) in meters walked.

  6. Functional exercise capacity

    Time frame: 3 months

    One-minute sit-to-stand test (1MSTS) in repetitions performed.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

CAir: Quality-of-Life Management for COPD Patients

Acronym: CAir

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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