An mHealth App for Fibromyalgia-like Post-COVID-19 Syndrome: Protocol for the Analysis of User Experience and Clinical Data

Background: Post-COVID-19 syndrome, also referred as "long covid," describes persisting symptoms after SARS-CoV-2 infection, including myalgia, fatigue, respiratory, or neurological symptoms. Objective symptoms are often lacking, thus resembling a fibromyalgia-like syndrome. Digital therapeutics have shown efficiency in similar chronic disorders such as fibromyalgia, offering specific disease monitoring and interventions such as cognitive behavioral therapy or physical and respiratory exercise guidance.

Objective: This protocol aims to study the requirements and features of a new mobile health (mHealth) app among patients with fibromyalgia-like post-COVID-19 syndrome in a clinical trial.

Methods: We created a web application prototype for the post-COVID-19 syndrome called "POCOS," as a web-based rehabilitation tool aiming to improve clinical outcomes. Patients without organ damage or ongoing inflammation will be included in the study. App use will be assessed through user experience questionnaires, focus groups, and clinical data analysis. Subsequently, we will analyze cross-sectional and longitudinal clinical data.

Results: The developed mHealth app consists of a clinically adapted app interface with a simplified patient-reported outcome assessment, monitoring of medical interventions, and disease activity as well as web-based instructions for specific physical and respiratory exercises, stress reduction, and lifestyle instructions. The enrollment of participants is expected to be carried out in November 2021.

Conclusions: User experience plays an important role in digital therapeutics and needs to be clinically tested to allow further improvement. We here describe this process for a new app for the treatment of the fibromyalgia-like post-COVID-19 syndrome and discuss the relevance of the potential outcomes such as natural disease course and disease phenotypes.

International registered report identifier (irrid): PRR1-10.2196/32193.