Clinical trial NCT03834064: Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
Official title: Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2019-02-07
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

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) 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: Inclusion Criteria:

* 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 Criteria:

* Persons with IDD: Will be excluded (screen failure) if they are unable to cooperate or refuse the oral examination.
* Caregivers: There are no exclusions.

Primary outcomes:
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Change in caregiver self-efficacy from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
timeFrame: 12 months
measure: Change in caregiver outcome expectancies from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
timeFrame: 12 months
measure: Change in caregiver behavioral capability from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: Change in oral hygiene practices of persons with IDD will be measured by a caregiver-reported Daily Oral Health Checklist in the experimental group compared to the control group from baseline to 4 months and 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References: