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

February 8, 2024 updated by: Luxembourg Institute of Health

Users' Expectations and Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice: a Mixed-methods Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The COVID-19 pandemic accelerated the use of remote patient monitoring in clinical practice or research for safety and emergency reasons, justifying the need for innovative digital health solutions to monitor key parameters or symptoms related to COVID-19 or Long COVID. A panel of experts from the National Institute for Health and Care Excellence (NICE) recommended the development of telemonitoring and encouraged self-management of acute and Long COVID symptoms in a tailored and accessible way for each patient.

Voice is an interesting approach to use for telemonitoring as it is easy-to-collect, quick, energy efficient, and inducing less burden for patients. To bring vocal biomarkers of different symptoms into clinical and real-life practice, they have to be implemented in a digital health solution, for example a smartphone application.

It is crucial to involve the end-users in the development of such a digital health solution and in this project involve them during the entire project course.

The study protocol, the participant's documents, and the questionnaires have been reviewed by both Long COVID patients and HCPs prior to submission.

The co-design process will consist in 3 steps, each involving both patients and HCPs:

  • Step 1. An online survey to assess acceptability, expectancies and define the general specifications of the digital health solution based on vocal biomarkers
  • Step 2. Individual interviews based on the results of the online survey, to deeply discuss the same themes than in the survey and to define the main specification of the solution
  • Step 3. Focus groups to present prototypes of the digital health solution and to collect user's comments and suggestions At each step participants will receive feedback from the previous step. Finally, participants with Long COVID and HCPs willing to be deeply involved in our research will be invited to co-author the scientific article presenting the results of this research.

The project is based on a mixed methods study and will integrate both qualitative and quantitative methods. Participants will be invited to participate in:

1. Online anonymous survey 2 Online semi-structured individual interviews 3. Online Focus groups

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Strassen, Luxembourg
        • Luxembourg Institute of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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
Healthcare professionals in charge of Long COVID patients
Other: survey, interviews and focus groups

The 2 groups of participants will be invited to:

  • complete an anonymous online survey
  • participate in individual semi-structured interviews and 2 focus groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of barriers and facilitators regarding the use of voice to self-monitor or screen for Long COVID symptoms
Time Frame: At baseline
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
Time Frame: At baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxembourg Institute of Health

Investigators

  • Principal Investigator: Aurelie FISCHER, MSc, Luxembourg Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UpcomingVoice

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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