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CompletedNCT05864027Updated Mar 12, 2024

Oral Health Recovery Group

An interventional study of Peer-led Oral Health Recovery Group and Educational Video about Oral Health in Oral Health, Dental Care and Psychiatric Diagnosis, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by University of Michigan · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oral Health
  • Dental Care
  • Psychiatric Diagnosis

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03

In context

Mental Disorders

2,109 studies on the registry are indexed under Mental Disorders; 417 are open to participants now.

This study's enrollment of 62 is below the median of 94 across 1,576 interventional studies indexed under Mental Disorders.

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Lead sponsor

University of Michigan is the lead sponsor of 1,476 studies on the registry; 197 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Peer-led Oral Health Recovery educational group

    Behavioral: Peer-led Oral Health Recovery Group

  • Active comparator
    Educational Video

    Behavioral: Educational Video about Oral Health

Interventions

  • BehavioralPeer-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."

  • BehavioralEducational 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

Secondary outcomes

  1. Odds ratio of participants who reported seeking dental care

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

    Time frame: 2 months

07

Study locations

2 sites
  • Justice in Mental Health Organization (JIMHO)
    Lansing, Michigan 48933, United States
  • Community Mental Health (Towner)
    Ypsilanti, Michigan 48198, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05864027
Lead sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation
Responsible party
Adrienne Lapidos (Clinical Assistant Professor, Psychiatry, University of Michigan) — Principal investigator
First posted
May 18, 2023
Start date
Apr 13, 2023
Primary completion
Dec 7, 2023
Completion
Dec 20, 2023
Last update
Mar 12, 2024

Study contacts

Adrienne Lapidos, PhD
principal investigator · University of Michigan Medical School, Psychiatry

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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