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Clinical Trials/NCT05546918
NCT05546918CompletedNot Applicable

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

Luxembourg Institute of Health1 site in 1 country125 target enrollmentStarted: October 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
125
Locations
1
Primary Endpoint
Evaluation of barriers and facilitators regarding the use of voice to self-monitor or screen for Long COVID symptoms

Study Overview

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.

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:

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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..)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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