Back to resultsOral Health Recovery Group
Primary Purpose
Oral Health, Dental Care, Psychiatric Diagnosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-led Oral Health Recovery Group
Educational Video about Oral Health
Sponsored by
About this trial
This is an interventional health services research trial for Oral Health
Eligibility Criteria
Inclusion Criteria: An adult member/consumer with the selected site (JIMHO or Washtenaw CMH) Ability to understand and willingness to read a consent terms handout and discussion Participant must understand/read/speak English Exclusion Criteria: Not a member/consumer with the site Not able to understand and/or not willing to read consent terms handout Does not understand/read/speak English
Sites / Locations
- Justice in Mental Health Organization (JIMHO)
- Community Mental Health (Towner)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peer-led Oral Health Recovery educational group
Educational Video
Arm Description
Outcomes
Primary Outcome Measures
Average subject-level change between pre- and post-surveys
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.
The 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.
Secondary Outcome Measures
Odds ratio of participants who reported seeking dental care
Odds ratio comparing the odds of seeking care in the two arms.
Full Information
NCT ID
NCT05864027
First Posted
April 12, 2023
Last Updated
May 8, 2023
Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield Foundation of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05864027
Brief Title
Oral Health Recovery Group
Official Title
Oral Health Recovery: A Peer-Delivered Oral Health Intervention for Individuals With Psychiatric Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield Foundation of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Health, Dental Care, Psychiatric Diagnosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peer-led Oral Health Recovery educational group
Arm Type
Experimental
Arm Title
Educational Video
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Peer-led Oral Health Recovery Group
Intervention 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."
Intervention Type
Behavioral
Intervention Name(s)
Educational Video about Oral Health
Intervention 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.
Primary Outcome Measure Information:
Title
Average subject-level change between pre- and post-surveys
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.
The 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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Odds ratio of participants who reported seeking dental care
Description
Odds ratio comparing the odds of seeking care in the two arms.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An adult member/consumer with the selected site (JIMHO or Washtenaw CMH)
Ability to understand and willingness to read a consent terms handout and discussion
Participant must understand/read/speak English
Exclusion Criteria:
Not a member/consumer with the site
Not able to understand and/or not willing to read consent terms handout
Does not understand/read/speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne Lapidos, PhD
Organizational Affiliation
University of Michigan Medical School, Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Justice in Mental Health Organization (JIMHO)
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48933
Country
United States
Facility Name
Community Mental Health (Towner)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Health Recovery Group
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