Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 4:32 PM
Study NCT ID:
NCT07217366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-16
First Post:
2025-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech-to-text Tool for Heart Failure Patient-Reported Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-10-13', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time', 'timeFrame': '~3 months', 'description': 'Time to complete AI Voice Assistant call and Paper Survey'}], 'primaryOutcomes': [{'measure': 'Accuracy of AI Voice Assistant Compared With Expert Extraction', 'timeFrame': '~3 months', 'description': "Agreement between AI-generated summaries and expert-reviewed responses (study staff extraction of participants' responses from audio recordings). The responses will be scored on a numerical scale, ranging from 0-17 points with higher points representing greater accuracy of the AI-generated summaries compared to expert-reviewed responses."}], 'secondaryOutcomes': [{'measure': 'Usability of AI Voice Assistant', 'timeFrame': '~3 months', 'description': 'Measured using the System Usability Scale (SUS), a validated 10-item questionnaire rated on a 5-point Likert scale, with total scores ranging from 0-100'}, {'measure': 'Agreement between AI Voice Assistant Compared With Patient Self-Reported Written Responses', 'timeFrame': '~3 months', 'description': 'We will compare agreement the AI Voice Assistant summary to patient-reported responses on the same data elements, including vital signs (heart rate, blood pressure, weight) and 14 symptom and health status questions. The responses will be scored on a numerical scale, ranging from 0-17 points with higher points representing higher agreement of the AI-generated summaries compared to expert-reviewed responses.'}, {'measure': 'Symptom Scores', 'timeFrame': '~3 months', 'description': 'Symptom scores based on the responses to questions obtained from AI Voice Assistant and written responses'}, {'measure': 'Qualitative Feedback', 'timeFrame': '~3 months', 'description': "Open-ended questions inquiring about participants' likes, dislikes, and suggestions for improvements"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial intelligence', 'Speech-to-text', 'Patient-reported data', 'Digital health', 'Patient self-care'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to see whether this type of Artificial Intelligence (AI) Voice Assistant can reliably capture patient-reported health information to support communication between patients and their healthcare team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults with heart failure receiving cardiology care at Stanford University\n\nExclusion Criteria:\n\n* Diminished decision-making capacity\n* Inability to understand and communicate in English sufficiently to complete study procedures\n* Inability to complete study procedures to the best of the participant's and investigator's knowledge\n* Any disorder or condition that, in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures or completion"}, 'identificationModule': {'nctId': 'NCT07217366', 'briefTitle': 'Speech-to-text Tool for Heart Failure Patient-Reported Data', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Testing a Speech-to-text Tool for Heart Failure Patient-Reported Data', 'orgStudyIdInfo': {'id': '79867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI Voice Assistant', 'description': 'Participants in the AI Voice Assistant arm will complete two activities: (1) an interaction with the AI Voice Assistant tool and (2) Paper survey that includes the same questions asked by AI voice assistant. Half of the participants will use the AI Voice Assistant first, while the other half will begin with the paper survey.', 'interventionNames': ['Other: Artificial intelligence speech-to-text tool']}], 'interventions': [{'name': 'Artificial intelligence speech-to-text tool', 'type': 'OTHER', 'description': 'Pilot testing of speech-to-text tool using artificial intelligence', 'armGroupLabels': ['AI Voice Assistant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Alexander Sandhu, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'December 2025-December 2026', 'ipdSharing': 'YES', 'description': 'Investigators can provide documents including the study protocol, study analysis plan, and informed consent form of the study to researchers who request the information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Alexander Sandhu', 'investigatorAffiliation': 'Stanford University'}}}}