Quality-of-Life Management for COPD Patients

NCT04373070 | Completed

• 1 other identifier: 2020-00707
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Chronic Respiratory Disease

Keywords

telemonitoring; chatbot; multimodal intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Symptom burden

  3 months

• Spirometry

  3 months

• Spirometry

  3 months

• Accelerometry

  3 months

• Functional exercise capacity

  3 months

Study Arms (2)

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.

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.

Combination Product: CAir

Interventions

CAir 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); chatbot-based intervention programme (intervention)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed COPD according to GOLD-guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33090112 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

carboxyaminoimidazole ribotide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian F Clarenbach, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 4, 2020
• Study Start: February 3, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CH (1)