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Quality-of-Life Management for COPD Patients (CAir)

Primary Purpose

Copd, Chronic Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CAir
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Copd focused on measuring telemonitoring, chatbot, multimodal intervention

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

chatbot-based intervention programme (intervention)

Usual care group (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Health-related quality-of-life (HrQoL)
St. George Respiratory Questionnaire (SGRQ). Scoring: Scores range from 0 to 100, with higher scores indicating more limitations.

Secondary Outcome Measures

Symptom burden
COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms.
Spirometry
Forced expiratory volume in one second (FEV1) in liters and percent predicted.
Spirometry
Forced vital capacity (FVC) in liters and percent predicted.
Accelerometry
Daily step count (number of steps)
Functional exercise capacity
Six-minute walk test (6MWT) in meters walked.
Functional exercise capacity
One-minute sit-to-stand test (1MSTS) in repetitions performed.

Full Information

First Posted
April 24, 2020
Last Updated
November 6, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04373070
Brief Title
Quality-of-Life Management for COPD Patients
Acronym
CAir
Official Title
CAir: Quality-of-Life Management for COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Chronic Respiratory Disease
Keywords
telemonitoring, chatbot, multimodal intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chatbot-based intervention programme (intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group (control)
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
CAir
Intervention Description
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 Measure Information:
Title
Health-related quality-of-life (HrQoL)
Description
St. George Respiratory Questionnaire (SGRQ). Scoring: Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Symptom burden
Description
COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms.
Time Frame
3 months
Title
Spirometry
Description
Forced expiratory volume in one second (FEV1) in liters and percent predicted.
Time Frame
3 months
Title
Spirometry
Description
Forced vital capacity (FVC) in liters and percent predicted.
Time Frame
3 months
Title
Accelerometry
Description
Daily step count (number of steps)
Time Frame
3 months
Title
Functional exercise capacity
Description
Six-minute walk test (6MWT) in meters walked.
Time Frame
3 months
Title
Functional exercise capacity
Description
One-minute sit-to-stand test (1MSTS) in repetitions performed.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian F Clarenbach, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
upon reasonable request
Citations:
PubMed Identifier
33090112
Citation
Gross C, Kohlbrenner D, Clarenbach CF, Ivankay A, Brunschwiler T, Nordmann Y, V Wangenheim F. A Telemonitoring and Hybrid Virtual Coaching Solution "CAir" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Oct 22;9(10):e20412. doi: 10.2196/20412.
Results Reference
derived

Learn more about this trial

Quality-of-Life Management for COPD Patients

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