Quality-of-Life Management for COPD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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CAir: Quality-of-Life Management for COPD Patients

Conditions
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Copd, Chronic Respiratory Disease

Intervention / Treatment
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* Combination Product: CAir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chatbot-based intervention programme (intervention)<br>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<br>* 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.<br>|
| Other: Usual care group (control)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality-of-life (HrQoL) | St. George Respiratory Questionnaire (SGRQ). Scoring: Scores range from 0 to 100, with higher scores indicating more limitations. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden | COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms. | 3 months | 
| Spirometry | Forced expiratory volume in one second (FEV1) in liters and percent predicted. | 3 months | 
| Spirometry | Forced vital capacity (FVC) in liters and percent predicted. | 3 months | 
| Accelerometry | Daily step count (number of steps) | 3 months | 
| Functional exercise capacity | Six-minute walk test (6MWT) in meters walked. | 3 months | 
| Functional exercise capacity | One-minute sit-to-stand test (1MSTS) in repetitions performed. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemonitoring, chatbot, multimodal intervention