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Trial record 1 of 1 for:    NCT04373070
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Quality-of-Life Management for COPD Patients (CAir)

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ClinicalTrials.gov Identifier: NCT04373070
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Copd Chronic Respiratory Disease Combination Product: CAir Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CAir: Quality-of-Life Management for COPD Patients
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: chatbot-based intervention programme (intervention)
Participants randomised to the intervention group will receive a CAir desk and a chatbot-based intervention programme for a period of 12 weeks. The CAir desk is supplied to assess HrQoL, physical activity, and spirometry data. The first week is equal to the procedure in the control group (for details see paragraph below) and serves for baseline measurements of daily physical activity. Starting in week 2 of the study duration, participants receive feedback on their daily physical activity through the CAir chatbot application and aim to increase their daily step count by 15% from baseline. Furthermore, the CAir chatbot provides several components of the "Living well with COPD" programme (e.g. educational content, information on exercise training) to the patient.
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.

Usual care group (control)
Participants randomised to the control group receive usual care and a CAir desk for a period of 12 weeks. The CAir desk is supplied to assess daily symptom burden, physical activity, and spirometry data. In contrast to the intervention group, participants do not receive feedback or scores of the daily reported CAT and daily physical activity.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373070


Contacts
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Contact: Christian F Clarenbach, MD +41 44 255 17 12 christian.clarenbach@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Christian F Clarenbach, MD    +41 44 255 17 12    christian.clarenbach@usz.ch   
Contact: Dario Kohlbrenner, MSc    +41 43 253 08 42    dario.kohlbrenner@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Christian F Clarenbach, MD University of Zurich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04373070    
Other Study ID Numbers: 2020-00707
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: upon reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
telemonitoring
chatbot
multimodal intervention
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases