Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05546918
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of barriers and facilitators regarding the use of voice to self-monitor or screen for Long COVID symptoms', 'timeFrame': 'At baseline', 'description': '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'}, {'measure': 'Definition of the specifications of a digital health solution based on vocal biomarkers to monitor and screen for COVID-19 related symptoms', 'timeFrame': 'At baseline', 'description': '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..)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-Acute COVID-19', 'symptoms', 'vocal biomarkers', 'co-design', 'Digital health solution'], 'conditions': ['COVID-19', 'Post-Acute COVID-19']}, 'referencesModule': {'references': [{'pmid': '34056518', 'type': 'BACKGROUND', 'citation': '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': '35983269', 'type': 'BACKGROUND', 'citation': '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': '34941554', 'type': 'BACKGROUND', 'citation': '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': '37335611', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTo achieve this objective the UpcomingVoice study will determine:\n\n* 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\n* 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.\n\nThe project consists in 2 separate parts : one anonymous online survey and one qualitative part based on semi-structured interviews and focus groups.\n\nThe results of this study will be the specifications of a voice-based digital health solution.', 'detailedDescription': "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.\n\nVoice 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.\n\nIt 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.\n\nThe study protocol, the participant's documents, and the questionnaires have been reviewed by both Long COVID patients and HCPs prior to submission.\n\nThe co-design process will consist in 3 steps, each involving both patients and HCPs:\n\n* Step 1. An online survey to assess acceptability, expectancies and define the general specifications of the digital health solution based on vocal biomarkers\n* 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\n* 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.\n\nThe project is based on a mixed methods study and will integrate both qualitative and quantitative methods. Participants will be invited to participate in:\n\n1\\. Online anonymous survey 2 Online semi-structured individual interviews 3. Online Focus groups"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with persisting symptoms related to COVID-19 (With Long COVID diagnosis or not) or Healthcare professional in charge of Long COVID patients\n* Adults (\\>18 years)\n* Male or female\n* French speaking people'}, 'identificationModule': {'nctId': 'NCT05546918', 'acronym': 'UpcomingVoice', 'briefTitle': 'Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Luxembourg Institute of Health'}, 'officialTitle': "Users' Expectations and Co-design of a Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 Using Voice: a Mixed-methods Study", 'orgStudyIdInfo': {'id': 'UpcomingVoice'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'People with Long COVID', 'description': 'Any people with persisting symptoms related to COVID-19 (With a Long COVID diagnosis or not)', 'interventionNames': ['Other: survey, interviews and focus groups']}, {'label': 'Healthcare Professional', 'description': 'Healthcare professionals in charge of Long COVID patients', 'interventionNames': ['Other: survey, interviews and focus groups']}], 'interventions': [{'name': 'survey, interviews and focus groups', 'type': 'OTHER', 'description': 'The 2 groups of participants will be invited to:\n\n* complete an anonymous online survey\n* participate in individual semi-structured interviews and 2 focus groups', 'armGroupLabels': ['Healthcare Professional', 'People with Long COVID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strassen', 'country': 'Luxembourg', 'facility': 'Luxembourg Institute of Health', 'geoPoint': {'lat': 49.62056, 'lon': 6.07333}}], 'overallOfficials': [{'name': 'Aurelie FISCHER, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luxembourg Institute of Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luxembourg Institute of Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}