Co-design of a voice-based digital health solution to monitor persisting symptoms related to COVID-19: protocol for the UpcomingVoice mixed-methods study (Preprint)

BACKGROUND The need for new telemonitoring solutions has been raised by the COVID-19 pandemic, in particular as a tool to monitor Long COVID symptoms. 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 to ensure acceptance of this innovative approach by its potential users, namely people with persisting COVID-19-related symptoms, with or without a Long COVID diagnosis and healthcare professionals involved in Long COVID care, it is crucial to include them in the entire development process. OBJECTIVE The objectives of the UpcomingVoice study are 1/ to define the most relevant aspects of their daily life that people with Long COVID would like to be improved, 2/ to assess how the use of voice and vocal biomarkers could be a potential solution to help them and 3/ to 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 online survey followed by a qualitative part based on semi-structured individual interviews and focus groups. People with Long COVID (PWLCs) and healthcare professionals (HCPs) in charge of Long COVID patients will be invited to participate in this fully online study. 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 with a thematic analysis approach. RESULTS The study was approved by the National Research Ethics Committee of Luxembourg (study number 202208/04) in August 2022 and started in October 2022 with the launch of the online survey. Data collection will be completed in September 2023 and expected 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 the use of voice and vocal biomarkers could meet these needs and co-develop a tailored voice-based digital health solution with its future end-users. Potential transferability to other diseases will be explored, which will contribute to the deployment of vocal biomarkers in general. CLINICALTRIAL Clinicaltrials.gov: NCT05546918