Status:
COMPLETED
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Oral Health
Eligibility:
All Genders
18-75 years
Phase:
NA
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 inte...
Detailed Description
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) caregiv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Persons with IDD: Will be excluded (screen failure) if they are unable to cooperate or refuse the oral examination.
- Caregivers: There are no exclusions.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT03834064
Start Date
June 1 2018
End Date
November 30 2021
Last Update
October 17 2023
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202