Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities (OHPROM)

University of Louisville (UOFL)

Status: Completed

Conditions: Oral Health

Treatments: Behavioral: Oral health promotion strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03834064

16020E

U01DE025833 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 412 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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412 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Oral health promotion strategy

Control

No Intervention group

Description:

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.