COVID-19UpcomingVoiceNCT05546918
Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice
An observational study of COVID-19 and Post-Acute COVID-19, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Post-Acute COVID-19
- What is being tested?
- survey, interviews and focus groups
- How many people
- 125 participants
- Where
- 1 siteLuxembourg
- Study dates
- 1 Oct 2022to 8 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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:
- Online anonymous survey 2 Online semi-structured individual interviews 3. Online Focus groups
- Conditions
- COVID-19, Post-Acute COVID-19
- Being tested
- survey, interviews and focus groups
- Keywords
- Post-Acute COVID-19, symptoms, vocal biomarkers, co-design, Digital health solution
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey, interviews and focus groupsOther
The 2 groups of participants will be invited to:
- complete an anonymous online survey
- participate in individual semi-structured interviews and 2 focus groups
| Study group | Role | What they receive |
|---|---|---|
| People with Long COVID | Any people with persisting symptoms related to COVID-19 (With a Long COVID diagnosis or not) Receives: Other: survey, interviews and focus groups | |
| Healthcare Professional | Healthcare professionals in charge of Long COVID patients Receives: Other: survey, interviews and focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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..)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Oct 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurelie FISCHER, MSc, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546918
- Sponsor's protocol ID
- UpcomingVoice
- Acronym
- UpcomingVoice
- Status last verified
- Feb 2024
- First submitted
- 12 Sep 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34056518Fischer 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.
PubMed 35983269Aguayo 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.
PubMed 34941554Fischer 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.
PubMed 37335611
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05546918
- Acronym / sponsor ID
- UpcomingVoice / UpcomingVoice
- Conditions
- COVID-19, Post-Acute COVID-19
- Keywords
- Post-Acute COVID-19, symptoms, vocal biomarkers, co-design, Digital health solution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Online anonymous survey 2 Online semi-structured individual interviews 3. Online Focus groups
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Long COVID | – | Other: survey, interviews and focus groupsAny people with persisting symptoms related to COVID-19 (With a Long COVID diagnosis or not) |
| Healthcare Professional | – | Other: survey, interviews and focus groupsHealthcare professionals in charge of Long COVID patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey, interviews and focus groupsThe 2 groups of participants will be invited to: * complete an anonymous online survey * participate in individual semi-structured interviews and 2 focus groups | Other | Healthcare Professional, People with Long COVID |
Primary outcome
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
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..)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 34056518Fagherazzi 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.
- Background: PubMed 35983269Fischer 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.
- Background: PubMed 34941554Aguayo 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.
- Derived from this study: PubMed 37335611Fischer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelie FISCHER, MSc principal investigator
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Post-Acute COVID-19, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of barriers and facilitators regarding the use of voice to self-monitor or screen for Long COVID symptoms (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05546918, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.