Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05864027
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Health Recovery Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average subject-level change between pre- and post-surveys', 'timeFrame': '2 months', 'description': 'To analyze process data generated by the peers, a custom web-based Peer Encounter Form will be employed using Qualtrics Survey Software. Peers will complete encounter forms after each group and follow up. Fields include time spent, unique and total encounters, topics covered, participant engagement, and any knowledge of participants\' seeking out or utilizing dental care.\n\nThe primary analyses will compare the change in total scores on an oral health knowledge questionnaire and an oral health confidence/activation questionnaire based primarily on the transtheoretical model of change. These comparisons will be conducted as a comparison of the average subject-level improvements between pre- and post-surveys ("change scores") between the primary intervention (peer-led Oral Health Recovery Group) and the comparator video intervention.'}], 'secondaryOutcomes': [{'measure': 'Odds ratio of participants who reported seeking dental care', 'timeFrame': '2 months', 'description': 'Odds ratio comparing the odds of seeking care in the two arms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Health', 'Dental Care', 'Psychiatric Diagnosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test a brief, peer-led group-based oral health educational intervention - called the "Oral Health Recovery Group" - designed for individuals with psychiatric disabilities.', 'detailedDescription': 'Participants at each site will obtain either: a) a Peer-led Oral Health Recovery educational group, representing the primary intervention; or b) viewing of an educational video about oral health, representing the comparison intervention. After participating in either condition, an onsite Peer staff member will offer to help the participant make a dentist appointment. They will follow up with the participant as needed for a two-month period to help arrange dental care and follow up on any dental self-care goals established by the participant, such as purchasing toothpaste with fluoride.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An adult member/consumer with the selected site (JIMHO or Washtenaw CMH)\n* Ability to understand and willingness to read a consent terms handout and discussion\n* Participant must understand/read/speak English\n\nExclusion Criteria:\n\n* Not a member/consumer with the site\n* Not able to understand and/or not willing to read consent terms handout\n* Does not understand/read/speak English'}, 'identificationModule': {'nctId': 'NCT05864027', 'briefTitle': 'Oral Health Recovery Group', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Oral Health Recovery: A Peer-Delivered Oral Health Intervention for Individuals With Psychiatric Disabilities', 'orgStudyIdInfo': {'id': 'HUM00219880'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer-led Oral Health Recovery educational group', 'interventionNames': ['Behavioral: Peer-led Oral Health Recovery Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Video', 'interventionNames': ['Behavioral: Educational Video about Oral Health']}], 'interventions': [{'name': 'Peer-led Oral Health Recovery Group', 'type': 'BEHAVIORAL', 'description': 'The interactive Oral Health Recovery group will be centered around the tailored materials previously developed, with topics such as "it\'s never too late to make a change," "oral health and whole health," "taking care of your teeth," and "going to the dentist."', 'armGroupLabels': ['Peer-led Oral Health Recovery educational group']}, {'name': 'Educational Video about Oral Health', 'type': 'BEHAVIORAL', 'description': 'The video comparison will be pulled from Toothflix 2.0 Patient Education DVD Series, which are patient education videos developed by the American Dental Association.', 'armGroupLabels': ['Educational Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48933', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Justice in Mental Health Organization (JIMHO)', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48198', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Community Mental Health (Towner)', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'Adrienne Lapidos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Medical School, Psychiatry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor, Psychiatry', 'investigatorFullName': 'Adrienne Lapidos', 'investigatorAffiliation': 'University of Michigan'}}}}