Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 5:34 AM
Study NCT ID:
NCT04432792
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The California Home Abortion by Telehealth (CHAT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6020}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of participants with a successful abortion', 'timeFrame': 'Documented resolution of pregnancy, for most patients assessed at 7 days', 'description': 'The proportion of participants who have a successful abortion defined as complete abortion without continuing pregnancy, need for manual vacuum aspiration or an additional round of treatment to complete the abortion.'}, {'measure': 'The proportion of participants reporting satisfaction with telehealth for abortion', 'timeFrame': 'Documented satisfaction measured at approximately 4 weeks follow up', 'description': 'The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.'}, {'measure': 'The proportion of participants reporting they would use the telehealth option again if needed', 'timeFrame': 'Documented at approximately 4 weeks follow up', 'description': 'The proportion of participants reporting they would use the telehealth option again if needed'}, {'measure': 'The total percentage of participants who carried out the study tasks as directed.', 'timeFrame': 'Documented at the 7 day follow up survey', 'description': 'The total percentage of participants who carried out the study tasks as directed.'}], 'secondaryOutcomes': [{'measure': 'The total percentage of participants who experienced a major adverse event', 'timeFrame': 'Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants', 'description': 'Major adverse events, either reported by the patient or documented through clinical records. Major adverse events will be defined as any abortion requiring blood transfusion, surgery, or hospitalization'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Telehealth', 'Telephone', 'Remote'], 'conditions': ['Abortion Early']}, 'descriptionModule': {'briefSummary': 'This study aims to assess efficacy and safety outcomes of a telehealth model of abortion care. The study will compare efficacy of this model to usual in-clinic care based on published rates. It will also investigate participant acceptability and feasibility of this model of care.', 'detailedDescription': "There are 2 components to the study:\n\n1. A clinical records review on all patients\n2. A survey study on a subset of patients who agree to participate.\n\nClinical Records Review: We will examine medical chart data on all patients from partnered telehealth providers to analyze efficacy and safety outcomes for medication abortion. These medical chart data will include medical/pregnancy history and abortion outcome and de-identified apart from date of birth, zip code, and dates of service.\n\nSurvey Study: Following completion of the telehealth provider's standard medical screening, all patients eligible to receive care through the telehealth provider will be directed to a page providing detailed information about the CHAT Evaluation Study and given the option to participate. Participation in the study involves completing our online questionnaires only. Being in the research study will not affect their care or treatment plan. Declining to participate in our research study will not affect their care.\n\nIf interested, the patient will provide electronic consent and complete a baseline survey to report socio-demographic characteristics, pregnancy history, and reasons for interest in telehealth medication abortion services. An online follow-up survey will be administered 3-7 days after receiving mifepristone and then once again 4 weeks after taking mifepristone; assessments will include self-report of medication administration, adverse events, and satisfaction.\n\nAmong those who complete the study surveys, we will investigate the feasibility, time to abortion, efficacy, safety, and acceptability of telehealth provision of mifepristone, measured using a 4-week follow-up though open-ended and closed-ended survey questions. Individuals who opted not to take the medications will be asked a separate set of follow-up questions to collect data related to diversion, to better understand potential risks."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will aim to reach a diverse sample of medication abortion patients across the country in states where care is provided including California, New York, and Washington, thus far. In California alone, an estimated 50% of all abortions are medication abortions resulting in \\>66,000 medication abortions per year. California accounts for 20% of the nation's medication abortions.", 'genderDescription': 'Any pregnant person seeking medication abortion regardless of gender identity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Current patient of a participating telehealth platform for medication abortion (includes ages 13-64 years)\n2. Able to read and write in English or Spanish\n3. Willing to participate in enrollment survey and two follow-up surveys\n\nExclusion Criteria:\n\n1. Not a current patient of a participating telehealth platform for medication abortion\n2. Unable to read or write in English or Spanish\n3. Unwilling to participate in study surveys'}, 'identificationModule': {'nctId': 'NCT04432792', 'acronym': 'CHAT', 'briefTitle': 'The California Home Abortion by Telehealth (CHAT) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The California Home Abortion by Telehealth (CHAT) Study', 'orgStudyIdInfo': {'id': '20-32951'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical Records Review', 'description': 'We will receive clinical chart data from the telehealth providers on 3,000 patients (which could include the survey study participants, but we will not know their identities) which will include date of birth, zip code, and dates of service - but will otherwise be de-identified.'}, {'label': 'Study Survey Participants', 'description': 'We aim to enroll at least 3,000 participants to complete the study surveys.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Study survey participants will be administered 3 online surveys.', 'armGroupLabels': ['Study Survey Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Advancing New Standards in Reproductive Health (ANSIRH)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ushma Upadhyay, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Latinas for Reproductive Justice', 'class': 'UNKNOWN'}, {'name': 'UCGHI Center for Gender and Health Justice Center of Expertise', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}