Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 18, 2020
Date Accepted: Sep 1, 2020
"CAir", a Telemonitoring and Hybrid Virtual Coaching Solution for Patients Suffering from Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. It is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve the patients' disabilities. Technological progress and the digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable for a broad spectrum of patients with COPD without expanding costs of the intervention.
Objective:
This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and investigate its effects on the health-related quality-of-life of patients with COPD.
Methods:
A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group receive usual care and a CAir Desk (custom-built home disease monitoring device to telemonitor disease-relevant parameters) for 12 weeks, but no feedback or scores of the telemonitoring efforts and no virtual coaching. Participants randomized to the intervention group also receive a CAir Desk and, additionally, a hybrid digital coaching intervention for 12 weeks. As primary outcome, we measure the delta in health-related quality-of-life, which we assess with the St. George Respiratory Questionnaire (SGRQ), from baseline to week 12, the end of the intervention.
Results:
The development of the CAir Desk and virtual coach is completed. Recruitment to the trial will start in June 2020. We expect to start data collection by August 2020. Data collection is planned to have an overall duration of 18 months as we follow a multi-wave approach. We expect to complete the data collection by the end of 2021 and plan the dissemination subsequently.
Conclusions:
This is the first study investigating a combination of telemonitoring and hybrid virtual coaching in COPD patients. We investigate the effectiveness, efficacy, and usability of the proposed intervention and thus provide evidence to further develop application-based and chatbot-based disease monitoring and intervention in COPD. Clinical Trial: ClinicalTrials.gov identifier: NCT04373070
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