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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05546918
Recruitment Status : Not yet recruiting
First Posted : September 21, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Luxembourg Institute of Health

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.


Condition or disease Intervention/treatment
COVID-19 Post-Acute COVID-19 Other: survey, interviews and focus groups

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

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Users' Expectations and Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice: a Mixed-methods Study
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2023


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




Primary Outcome Measures :
  1. 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

  2. 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..)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05546918


Contacts
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Contact: Aurelie FISCHER, MSc +352 26970-230 aurelie.fischer@lih.lu
Contact: Gloria AGUAYO, MD, PhD +352 26970-770 gloria.aguayo@lih.lu

Locations
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Luxembourg
Luxembourg Institute of Health
Strassen, Luxembourg
Contact: Aurelie Fischer, MSc       aurelie.fischer@lih.lu   
Principal Investigator: Aurelie FISCHER, MSc         
Sub-Investigator: Gloria AGUAYO, PhD         
Sub-Investigator: Guy FAGHERAZZI, PhD         
Sponsors and Collaborators
Luxembourg Institute of Health
Investigators
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Principal Investigator: Aurelie FISCHER, MSc Luxembourg Institute of Health
Publications:
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Responsible Party: Luxembourg Institute of Health
ClinicalTrials.gov Identifier: NCT05546918    
Other Study ID Numbers: UpcomingVoice
First Posted: September 21, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luxembourg Institute of Health:
Post-Acute COVID-19
symptoms
vocal biomarkers
co-design
Digital health solution
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases