CopdCAirNCT04373070
Quality-of-Life Management for COPD Patients
A study testing CAir in people with Copd and Chronic Respiratory Disease, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd, Chronic Respiratory Disease
- What is being tested?
- CAir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Feb 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed COPD according to GOLD-guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAir: 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.
Read the 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.
- Conditions
- Copd, Chronic Respiratory Disease
- Being tested
- CAir
- Keywords
- telemonitoring, chatbot, multimodal intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAirCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| chatbot-based intervention programme (intervention) | Experimental | 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. Receives: Combination Product: CAir |
| Usual care group (control) | Other | 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. Receives: Combination Product: CAir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality-of-life (HrQoL)
St. George Respiratory Questionnaire (SGRQ). Scoring: Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 3 months
Secondary outcomes (6)
Symptom burden
COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms.
Measured: 3 months
Spirometry
Forced expiratory volume in one second (FEV1) in liters and percent predicted.
Measured: 3 months
Spirometry
Forced vital capacity (FVC) in liters and percent predicted.
Measured: 3 months
Accelerometry
Daily step count (number of steps)
Measured: 3 months
Functional exercise capacity
Six-minute walk test (6MWT) in meters walked.
Measured: 3 months
Functional exercise capacity
One-minute sit-to-stand test (1MSTS) in repetitions performed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start3 Feb 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian F Clarenbach, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373070
- Sponsor's protocol ID
- 2020-00707
- Acronym
- CAir
- Status last verified
- Nov 2022
- First submitted
- 24 Apr 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Publications
Kohlbrenner D, Kuhn M, Klay A, Sievi NA, Muszynski M, Ivankay A, Gross CS, Asisof A, Brunschwiler T, Clarenbach CF. Hybrid Virtual Coaching and Telemonitoring in COPD Management: The CAir Randomised Controlled Study. Int J Chron Obstruct Pulmon Dis. 2024 Dec 24;19:2739-2750. doi: 10.2147/COPD.S487105. eCollection 2024.
PubMed 39735636Gross 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.
PubMed 33090112
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAir: Quality-of-Life Management for COPD Patients
- ClinicalTrials.gov ID
- NCT04373070
- Acronym / sponsor ID
- CAir / 2020-00707
- Conditions
- Copd, Chronic Respiratory Disease
- Keywords
- telemonitoring, chatbot, multimodal intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.
| Arm | Type | Receives |
|---|---|---|
| chatbot-based intervention programme (intervention) | Experimental | Combination Product: CAirParticipants 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. |
| Usual care group (control) | Other | Combination Product: CAirParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed COPD according to GOLD-guidelines
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAirThe 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. | Combination product | Usual care group (control), chatbot-based intervention programme (intervention) |
Primary outcome
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.
6 secondary outcomes
Symptom burden
Time frame: 3 months
Spirometry
Time frame: 3 months
Spirometry
Time frame: 3 months
Accelerometry
Time frame: 3 months
Functional exercise capacity
Time frame: 3 months
Functional exercise capacity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 39735636Kohlbrenner D, Kuhn M, Klay A, Sievi NA, Muszynski M, Ivankay A, Gross CS, Asisof A, Brunschwiler T, Clarenbach CF. Hybrid Virtual Coaching and Telemonitoring in COPD Management: The CAir Randomised Controlled Study. Int J Chron Obstruct Pulmon Dis. 2024 Dec 24;19:2739-2750. doi: 10.2147/COPD.S487105. eCollection 2024.
- Derived from this study: PubMed 33090112Gross 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.
- Individual participant dataSharing planned: Yes. upon reasonable request
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian F Clarenbach, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAir in people with Copd and Chronic Respiratory Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality-of-life (HrQoL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373070, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.