Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-31 @ 1:13 PM
Study NCT ID:
NCT06790069
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of a Symptom Checker on Healthcare-seeking Decisions: a Mixed-Methods Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 968}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Socioeconomic background of users', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Subgroup analysis', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment'}, {'measure': 'Condition comparison', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Time to receiving advice', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Time to diagnosis', 'timeFrame': 'From data collection with participant enrolment to the completion of the follow-up survey send out 1 week after enrolment.'}, {'measure': 'Quantitative and qualitative information collected in the phone survey on demographics, health seeking behaviour and user experience with the symptom checker', 'timeFrame': 'Approx. 1-2 weeks after enrolment.'}], 'primaryOutcomes': [{'measure': 'Proportion of appropriate advice by the SC for mother and child', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.'}, {'measure': 'Proportion of safe advice by the SC for mother and child', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.'}], 'secondaryOutcomes': [{'measure': 'Potential prevention of a health problem in Perinatal Period for Mother or Child', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.'}, {'measure': 'Potential prevention of a SEVERE health problem in Perinatal Period for Mother or Child', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.'}, {'measure': 'Potential Occurrence of a health problem (adverse event) in Perinatal Period for Mother and Child', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.'}, {'measure': 'Potential Occurrence of a SEVERE health problem (severe adverse event) in Perinatal Period for Mother or Child', 'timeFrame': 'From data collection with participant enrolment to the completion of panel ratings, approximately 2-3 months after participant enrolment.'}, {'measure': 'Health seeking behaviour before and after using Ada+MomConnect', 'timeFrame': 'From data collection with participant enrolment to the completion of the follow-up survey send out 1 week after enrolment.'}, {'measure': 'Number of participants who consulted an HCP after using Ada+MomConnect', 'timeFrame': 'After completion of the follow-up survey send out 1 week after enrolment.'}, {'measure': 'Gaining of health information in a fast and standardised way', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Usability', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Time saved from avoiding unnecessary healthcare consultations', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Time saved and associated estimate of income retained through avoiding unnecessary healthcare consultations', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Healthcare resource utilisation', 'timeFrame': 'On the day of enrolment.'}, {'measure': 'Direct Healthcare costs', 'timeFrame': 'On the day of enrolment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maternal health', 'mobile health tools', 'symptom checker'], 'conditions': ['Maternal Health Care']}, 'descriptionModule': {'briefSummary': "The goal of this study is to evaluate the integration of a symptom checker (SC) into the MomConnect (MC) platform to support maternal healthcare in South Africa. The main questions it aims to answer are:\n\n* Does the SC provide safe and appropriate medical advice?\n* Does the SC help mothers make informed decisions about when and where to seek healthcare, saving time and money by avoiding unnecessary visits?\n* Does the SC improve access to care for those facing significant healthcare barriers?\n\nParticipants will answer survey questions before and after using the SC. A subset of participants will also be invited to participate in structured telephone interviews.\n\nThe study will help researchers assess the SC's impact on healthcare decisions and resource use in South Africa."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of users of MomConnect a program developed by the National Department of Health (NDOH) in South Africa and Reach Digital Health for pregnant women and young mothers.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women registered with MomConnect, who would like to assess their or their child's symptoms\n* At least 18 years of age\n* Women with access to WhatsApp\n* Capable of completing a symptom assessment in English\n\nExclusion Criteria:\n\n* Incapable of completing a symptom assessment in English via WhatsApp (e.g. due to illiteracy, language barrier, mental impairment or inebriation or other incapacity or lack of access to WhatsApp)"}, 'identificationModule': {'nctId': 'NCT06790069', 'acronym': 'SAFEMOM', 'briefTitle': 'Evaluating the Impact of a Symptom Checker on Healthcare-seeking Decisions: a Mixed-Methods Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ada Health GmbH'}, 'officialTitle': 'Safety and Feasibility of the Integration of Ada Into the Mobile MomConnect Information Service for Pregnant Women and New Mothers in South Africa', 'orgStudyIdInfo': {'id': 'StAP0012'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Reach Digital Health (formerly Praekelt.org)', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ada Health GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Reach Digital Health (formerly Praekelt.org)', 'class': 'UNKNOWN'}, {'name': 'Citizen Surveys', 'class': 'UNKNOWN'}, {'name': 'Rockefeller Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}