Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities

NCT03834064 | Completed DMC

• 2 other identifiers: 16020EU01DE025833
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II cluster randomized controlled trial of the (OHPROM) strategy/intervention will be conducted in partnership with several organizations that provide residential services for persons with intellectual developmental disabilities (IDD) in north central Kentucky and southern Indiana. The investigators have identified a purposive sample of group homes, caregivers, and persons with IDD and have the support of these organizations.

Conditions

Oral Health

Outcome Measures

Primary Outcomes (2)

• The primary outcome of this study is the change in the oral health status of persons with IDD at 4 months and 12 months in comparison to the control group, after controlling for oral health status at baseline as measured by the Modified Gingival Index.

  Primary Outcome Measure the Modified Gingival Index (MGI). The MGI assesses the gingival condition, with scores ranging from 0 (no inflammation) to 4 (severe inflammation). Score range 0-128, higher is worse.

  12 months

• The primary outcome of this study is change in the oral health status of persons with IDD at 4 months and 12 months in comparison to the control group, after controlling for oral health status at baseline as measured by the Community Periodontal Index.

  Primary Outcome Measure the Community Periodontal Index (CPI). The CPI assesses periodontal disease from a score of 0 (healthy - absence of periodontal disease) to 4 (deep pockets - severe periodontal disease). Score range 1-40, higher is worse outcome.

  12 months

Secondary Outcomes (6)

• Change in caregiver self-efficacy from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.

  12 months

• Change in caregiver outcome expectancies from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.

  12 months

• Change in caregiver behavioral capability from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.

  12 months

• Secondary outcomes are change in caregiver perceptions of environmental influences from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.

  12 months

• Change in Oral hygiene practices of persons with IDD will be measured by a dental oral examination guided by the Simplified Oral Hygiene Index (OHI-S) from baseline to 4 months and 12 months in the experimental group compared to the control group.

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Homes where participants with intellectual/developmental disabilities reside will be randomly assigned to the intervention arm. Caregivers working in that home will receive the oral health promotion strategy/intervention over the course of a year.

Behavioral: Oral health promotion strategy

Control

NO INTERVENTION

Homes where participants with intellectual/developmental disabilities reside will be randomly assigned to the control arm. Caregivers in that home will not receive the oral health promotion strategy/intervention over the course of a year but will be offered a compressed intervention after a year.

Interventions

Oral health promotion strategy BEHAVIORAL

The proposed intervention is comprised of four components : (a) planned action including a behavioral contract Activity 1) with caregivers and action planning for oral health (Activity 2), (b) caregiver capacity building with didactic training (Activity 3), observational learning and caregiver practice (Activity 4); (c) environmental adaptations with location of oral health activities and reminder posters - physical environment (Activity 5) and administrative oral health support- (social environment (Activity 6); and (d) reinforcement with caregiver coaching (Activity 7).

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with IDD: To be eligible to participate in this study, an individual must meet all of the following criteria:
• Be a resident in a group or family home associated with one of the six partner organizations participating in this study
• Provide signed and dated informed consent form, to be signed by self or a legally authorized representative (LAR), if one has been appointed
• Be willing and able to comply with all study procedures and expect to be available for the duration of the study
• Be aged 18 to 75
• Have at least six teeth
• Have diagnosis of mild, moderate, severe, or profound intellectual and/or developmental disability
• Caregiver staff: To be eligible to participate in this study, caregiver staff must meet all of the following criteria:
• Work as a direct care staff member in a group/family home
• Provide signed and dated informed consent form
• Be willing to comply with all study procedures and be available for the duration of the study
• Be aged 18 to 75

You may not qualify if:

• Persons with IDD: Will be excluded (screen failure) if they are unable to cooperate or refuse the oral examination.

Sponsors & Collaborators

• University of Louisville: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The dentist assessing the oral health status of the intervention and control participants will be masked to participant group assignment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The primary objective of this study is to assess the direct effect of the OHPROM strategy on oral health status of persons with IDD at post intervention \[4-month\] and sustained \[12-month\] in comparison to the control group

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 7, 2019
• Study Start: June 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)