Oral Health Recovery Group

March 7, 2024 updated by: Adrienne Lapidos, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Lansing, Michigan, United States, 48933
        • Justice in Mental Health Organization (JIMHO)
      • Ypsilanti, Michigan, United States, 48198
        • Community Mental Health (Towner)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average subject-level change between pre- and post-surveys
Time Frame: 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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds ratio of participants who reported seeking dental care
Time Frame: 2 months
Odds ratio comparing the odds of seeking care in the two arms.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Blue Cross Blue Shield of Michigan Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Actual)

December 7, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00219880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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