Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice

NCT05546918 | Completed

• 1 other identifier: UpcomingVoice
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The UpcomingVoice project aims to co-design a digital health solution based on vocal biomarkers for screening and self-monitoring of frequently reported COVID-19-related symptoms with its end-users: 1) people with persisting COVID-19 related symptoms, with or without a Long COVID diagnosis and 2) healthcare professionals involved in the care of Long COVID patients. To achieve this objective the UpcomingVoice study will determine:

• The needs, expectancies, acceptability, fears, barriers and leverages of the end-users regarding the use of voice to self-monitor or screen for Long COVID symptoms
• The specifications that such a mobile application should meet in order to be considered acceptable and effective by its intended users in terms of technological aspects (type of device, type of voice recordings…), frequency of utilisation, design etc. The project consists in 2 separate parts : one anonymous online survey and one qualitative part based on semi-structured interviews and focus groups. The results of this study will be the specifications of a voice-based digital health solution.

Conditions

COVID-19; Post-Acute COVID-19

Keywords

Post-Acute COVID-19; symptoms; vocal biomarkers; co-design; Digital health solution

Outcome Measures

Primary Outcomes (2)

• Evaluation of barriers and facilitators regarding the use of voice to self-monitor or screen for Long COVID symptoms

  Specific questions will be asked in the online survey and during an individual online interview to identify the needs, expectancies, acceptability, fears, barriers and leverages regarding the use of voice as a monitoring tool

  At baseline

• Definition of the specifications of a digital health solution based on vocal biomarkers to monitor and screen for COVID-19 related symptoms

  Specific questions will be asked in the online survey, during an individual online interview and during focus groups regarding the main dimensions of a digital health solution (Engagement, functionality, aesthetics, information and general items ("Would you recommend", "Would you be interested in", etc..)

  At baseline

Study Arms (2)

People with Long COVID

Any people with persisting symptoms related to COVID-19 (With a Long COVID diagnosis or not)

Other: survey, interviews and focus groups

Healthcare Professional

Healthcare professionals in charge of Long COVID patients

Other: survey, interviews and focus groups

Interventions

survey, interviews and focus groups OTHER

The 2 groups of participants will be invited to: * complete an anonymous online survey * participate in individual semi-structured interviews and 2 focus groups

Healthcare Professional; People with Long COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participation in the study will be proposed to adults (men and women) with persisting COVID-19 related symptoms, with or without a Long COVID diagnosis and to healthcare professionals in charge of Long COVID patients.

You may qualify if:

• People with persisting symptoms related to COVID-19 (With Long COVID diagnosis or not) or Healthcare professional in charge of Long COVID patients
• Adults (\>18 years)
• Male or female
• French speaking people

Sponsors & Collaborators

• Luxembourg Institute of Health: lead

Study Sites (1)

Luxembourg Institute of Health

Strassen, Luxembourg

Location

Related Publications (4)

• Fagherazzi G, Fischer A, Ismael M, Despotovic V. Voice for Health: The Use of Vocal Biomarkers from Research to Clinical Practice. Digit Biomark. 2021 Apr 16;5(1):78-88. doi: 10.1159/000515346. eCollection 2021 Jan-Apr.

  PMID: 34056518 BACKGROUND

• Fischer A, Zhang L, Elbeji A, Wilmes P, Oustric P, Staub T, Nazarov PV, Ollert M, Fagherazzi G. Long COVID Symptomatology After 12 Months and Its Impact on Quality of Life According to Initial Coronavirus Disease 2019 Disease Severity. Open Forum Infect Dis. 2022 Aug 5;9(8):ofac397. doi: 10.1093/ofid/ofac397. eCollection 2022 Aug.

  PMID: 35983269 BACKGROUND

• Aguayo GA, Goetzinger C, Scibilia R, Fischer A, Seuring T, Tran VT, Ravaud P, Bereczky T, Huiart L, Fagherazzi G. Methods to Generate Innovative Research Ideas and Improve Patient and Public Involvement in Modern Epidemiological Research: Review, Patient Viewpoint, and Guidelines for Implementation of a Digital Cohort Study. J Med Internet Res. 2021 Dec 23;23(12):e25743. doi: 10.2196/25743.

  PMID: 34941554 BACKGROUND

• Fischer A, Aguayo GA, Oustric P, Morin L, Larche J, Benoy C, Fagherazzi G. 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. JMIR Res Protoc. 2023 Jun 19;12:e46103. doi: 10.2196/46103.

  PMID: 37335611 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Surveys and Questionnaires; Interviews as Topic; Focus Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aurelie FISCHER, MSc

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)