Oral Health Recovery Group

Oral Health Clinical Trial

Official title:

Oral Health Recovery: A Peer-Delivered Oral Health Intervention for Individuals With Psychiatric Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05864027
• Other study ID #: HUM00219880
• Status: Completed
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 20, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Care
• Mental Disorders
• Oral Health
• Psychiatric Diagnosis

Intervention

Behavioral:
• Peer-led Oral Health Recovery Group
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."
• Educational Video about Oral Health
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.

Locations

Country	Name	City	State
United States	Justice in Mental Health Organization (JIMHO)	Lansing	Michigan
United States	Community Mental Health (Towner)	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Secondary	Odds ratio of participants who reported seeking dental care	Odds ratio comparing the odds of seeking care in the two arms.	2 months