Quality-of-Life Management for COPD Patients

Not Applicable

Completed

• Conditions: Copd; Chronic Respiratory Disease
• Interventions: Combination Product: CAir

• Registration Number: NCT04373070
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-04
• Study Start: 2021-02-03
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care group (control)	CAir	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.
chatbot-based intervention programme (intervention)	CAir	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symptom burden	3 months	COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms.
Spirometry	3 months	Forced vital capacity (FVC) in liters and percent predicted.
Accelerometry	3 months	Daily step count (number of steps)
Functional exercise capacity	3 months	One-minute sit-to-stand test (1MSTS) in repetitions performed.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland