Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
NCT ID: NCT03834064
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
412 participants
INTERVENTIONAL
2018-06-01
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Intervention
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.
Oral health promotion strategy
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).
Control
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.
No interventions assigned to this group
Interventions
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Oral health promotion strategy
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).
Eligibility Criteria
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Inclusion 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 Criteria
* Caregivers: There are no exclusions.
18 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
University of Louisville
OTHER
Responsible Party
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Himabindu Dukka
Assistant Professor
Locations
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University of Louisville
Louisville, Kentucky, United States
Countries
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Other Identifiers
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16020E
Identifier Type: -
Identifier Source: org_study_id
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