Co-Design of a Voice-Based Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 (UpcomingVoice Study): Protocol for a Mixed Methods Study.

BACKGROUND: Between 10% and 20% of people with a COVID-19 infection will develop the so-called long COVID syndrome, which is characterized by fluctuating symptoms. Long COVID has a high impact on the quality of life of affected people, who often feel abandoned by the health care system and are demanding new tools to help them manage their symptoms. New digital monitoring solutions could allow them to visualize the evolution of their symptoms and could be tools to communicate with health care professionals (HCPs). The use of voice and vocal biomarkers could facilitate the accurate and objective monitoring of persisting and fluctuating symptoms. However, to assess the needs and ensure acceptance of this innovative approach by its potential users-people with persisting COVID-19-related symptoms, with or without a long COVID diagnosis, and HCPs involved in long COVID care-it is crucial to include them in the entire development process. OBJECTIVE: In the UpcomingVoice study, we aimed to define the most relevant aspects of daily life that people with long COVID would like to be improved, assess how the use of voice and vocal biomarkers could be a potential solution to help them, and determine the general specifications and specific items of a digital health solution to monitor long COVID symptoms using vocal biomarkers with its end users. METHODS: UpcomingVoice is a cross-sectional mixed methods study and consists of a quantitative web-based survey followed by a qualitative phase based on semistructured individual interviews and focus groups. People with long COVID and HCPs in charge of patients with long COVID will be invited to participate in this fully web-based study. The quantitative data collected from the survey will be analyzed using descriptive statistics. Qualitative data from the individual interviews and the focus groups will be transcribed and analyzed using a thematic analysis approach. RESULTS: The study was approved by the National Research Ethics Committee of Luxembourg (number 202208/04) in August 2022 and started in October 2022 with the launch of the web-based survey. Data collection will be completed in September 2023, and the results will be published in 2024. CONCLUSIONS: This mixed methods study will identify the needs of people affected by long COVID in their daily lives and describe the main symptoms or problems that would need to be monitored and improved. We will determine how using voice and vocal biomarkers could meet these needs and codevelop a tailored voice-based digital health solution with its future end users. This project will contribute to improving the quality of life and care of people with long COVID. The potential transferability to other diseases will be explored, which will contribute to the deployment of vocal biomarkers in general. TRIAL REGISTRATION: ClinicalTrials.gov NCT05546918; https://clinicaltrials.gov/ct2/show/NCT05546918. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46103.