Quality-of-Life Management for COPD Patients

NCT ID: NCT04373070

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2022-05-30

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.

Conditions

Copd; Chronic Respiratory Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CAir

Intervention Type: 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.

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.

Group Type: OTHER

CAir

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian F Clarenbach, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 33090112 (View on PubMed)

Other Identifiers

2020-00707

Identifier Type: -

Identifier Source: org_study_id