Oral Health Recovery Group

Sponsor
University of Michigan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05864027
Collaborator
Blue Cross Blue Shield Foundation of Michigan (Other)
60
2
2
12.6
30
2.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer-led Oral Health Recovery Group
  • Behavioral: Educational Video about Oral Health
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Oral Health Recovery: A Peer-Delivered Oral Health Intervention for Individuals With Psychiatric Disabilities
Actual Study Start Date :
Apr 13, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peer-led Oral Health Recovery educational group

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."

Active Comparator: Educational Video

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Average subject-level change between pre- and post-surveys [2 months]

    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

  1. Odds ratio of participants who reported seeking dental care [2 months]

    Odds ratio comparing the odds of seeking care in the two arms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Justice in Mental Health Organization (JIMHO) Lansing Michigan United States 48933
2 Community Mental Health (Towner) Ypsilanti Michigan United States 48198

Sponsors and Collaborators

  • University of Michigan
  • Blue Cross Blue Shield Foundation of Michigan

Investigators

  • Principal Investigator: Adrienne Lapidos, PhD, University of Michigan Medical School, Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adrienne Lapidos, Clinical Assistant Professor, Psychiatry, University of Michigan
ClinicalTrials.gov Identifier:
NCT05864027
Other Study ID Numbers:
  • HUM00219880
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023