Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT05317468
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2022-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction Assessed by IQFP', 'timeFrame': 'Baseline', 'description': 'Interpersonal Quality in Family Planning (IQFP) scale\n\nContinuous score: 11-55, higher scores indicate higher patient satisfaction Dichotomous: highest score (55) versus lower scores, highest score indicates highest patient satisfaction'}], 'secondaryOutcomes': [{'measure': '% of Patients Receiving Desired Contraceptive Method Assessed by Medical Record Review', 'timeFrame': '30 Days Post Baseline'}, {'measure': '% of Patients Reporting Barriers to Technology Use Assessed by Baseline Questionnaire', 'timeFrame': 'Baseline', 'description': 'Percentage of patients reporting limited access to mobile telephone or computer with video capabilities, unreliable telephone or internet service, and environmental distractors (i.e. loud noises, lack of privacy)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception', 'Health Care Utilization']}, 'descriptionModule': {'briefSummary': 'The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model.', 'detailedDescription': 'The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth. Participants will be randomized to receive counseling via video or telephone. We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to speak and read English\n* Access to video-capable technology\n\nExclusion Criteria:\n\n* Incarceration\n* Unable to provide informed consent secondary to language barrier or cognitive limitation'}, 'identificationModule': {'nctId': 'NCT05317468', 'briefTitle': 'Assessing Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pilot Randomized Controlled Trial to Assess Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits', 'orgStudyIdInfo': {'id': '202203067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video', 'description': 'Patients will complete contraceptive counseling using a video-based platform. Patients and counselors will have an audio and video connection.', 'interventionNames': ['Other: Contraceptive Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Telephone', 'description': 'Patients will complete contraceptive counseling on a telephone call. Patients and counselors will have an audio connection only.', 'interventionNames': ['Other: Contraceptive Counseling']}], 'interventions': [{'name': 'Contraceptive Counseling', 'type': 'OTHER', 'description': 'Patients will receive contraceptive counseling to review all available contraceptive methods prior to their visit with a clinician.', 'armGroupLabels': ['Telephone', 'Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Jennifer A Reeves, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}