Back to resultsOral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities (OHPROM)
Primary Purpose
Oral Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral health promotion strategy
Sponsored by
About this trial
This is an interventional treatment trial for Oral Health
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.
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in caregiver self-efficacy from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Caregivers will self-report self-efficacy using an adapted version of the 10-item General Self- Efficacy Scale (Schwarzer, 1995). The adaptation was made to the lead-in statement in order to ask about general self-efficacy of Caregivers as they provide support to residents' oral hygiene and dietary practices. Response choices are: Never, Almost, Sometimes, Fairly Often, and Very Often. Score range 0-40, higher is good.
Change in caregiver outcome expectancies from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Caregivers will self-report outcome expectancies using an adapted version of Kakudate et al.'s (2010) 6-item Outcome Expectancies Scale. Response choices are: Strongly Disagree, Disagree, Agree, and Strongly Agree. Score range 0-48, higher good
Change in caregiver behavioral capability from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Caregivers will self-report behavioral capability using an adapted version of Pradhan's (2016) Carer Activation Measure. Subscales of confidence (6 items) and skills (5 items) to measure behavioral capability. Response choices are: Strongly Disagree, Disagree, Agree, and Strongly Agree. Score range 0-44, higher is good.
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.
Caregivers will self-report environmental influences using a caregiver questionnaire developed specifically for this study, which assesses caregiver perceptions of the level of influence physical environmental influences (e.g., placement of posters as daily reminders) and social environmental influences (e.g., administrative support through policies and procedures). This is an 8-item scale. Response choices are: Strongly Disagree, Disagree, Agree, and Strongly Agree. Score range 0-32, higher is good.
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.
The OHI-S has two components: the Debris Index and the Calculus Index. Each of these indices represents numerical determinations ranging from 0 (None) to 3 (Covering 2/3rd of tooth surface) of the amount of debris or calculus found on the preselected tooth surfaces. The six surfaces examined for the OHI-S are selected from four posterior and two anterior teeth. The buccal surfaces of the selected upper molars and the lingual surfaces of the selected lower molars are inspected. In the anterior portion of the mouth, the labial surfaces of the upper right (11) and the lower left central incisors The average individual or group debris and calculus scores are combined to obtain the Simplified Oral Hygiene Index. The CI-S and DI-S values may range from 0 to 3; the OHI-S values from 0 to 6. Higher scores indicate a worse outcome.
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.
The Daily Oral Health Checklist will be completed daily by each Caregiver for three days at all three time points in the study. These data will be used to calculate an index to assess Oral Hygiene Practices of residents' use (daily - yes/no) of oral hygiene devices as well as whether adequate time (at least one minute daily) was spent on oral hygiene activities, and whether hygiene activities were completed alone or with caregiver assistance. Dietary practices of persons with IDD will also be measured by the 3-day Daily Oral Health Checklist and completed by Caregivers to assess the frequency and timing of food and beverages that are good and bad for teeth and if caregivers cooperation strategies.
Full Information
NCT ID
NCT03834064
First Posted
January 24, 2019
Last Updated
October 13, 2023
Sponsor
University of Louisville
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT03834064
Brief Title
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
Acronym
OHPROM
Official Title
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
Outcomes Assessor
Masking Description
The dentist assessing the oral health status of the intervention and control participants will be masked to participant group assignment.
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Oral health promotion strategy
Intervention 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).
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months
Title
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.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in caregiver self-efficacy from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Description
Caregivers will self-report self-efficacy using an adapted version of the 10-item General Self- Efficacy Scale (Schwarzer, 1995). The adaptation was made to the lead-in statement in order to ask about general self-efficacy of Caregivers as they provide support to residents' oral hygiene and dietary practices. Response choices are: Never, Almost, Sometimes, Fairly Often, and Very Often. Score range 0-40, higher is good.
Time Frame
12 months
Title
Change in caregiver outcome expectancies from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Description
Caregivers will self-report outcome expectancies using an adapted version of Kakudate et al.'s (2010) 6-item Outcome Expectancies Scale. Response choices are: Strongly Disagree, Disagree, Agree, and Strongly Agree. Score range 0-48, higher good
Time Frame
12 months
Title
Change in caregiver behavioral capability from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Description
Caregivers will self-report behavioral capability using an adapted version of Pradhan's (2016) Carer Activation Measure. Subscales of confidence (6 items) and skills (5 items) to measure behavioral capability. Response choices are: Strongly Disagree, Disagree, Agree, and Strongly Agree. Score range 0-44, higher is good.
Time Frame
12 months
Title
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.
Description
Caregivers will self-report environmental influences using a caregiver questionnaire developed specifically for this study, which assesses caregiver perceptions of the level of influence physical environmental influences (e.g., placement of posters as daily reminders) and social environmental influences (e.g., administrative support through policies and procedures). This is an 8-item scale. Response choices are: Strongly Disagree, Disagree, Agree, and Strongly Agree. Score range 0-32, higher is good.
Time Frame
12 months
Title
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.
Description
The OHI-S has two components: the Debris Index and the Calculus Index. Each of these indices represents numerical determinations ranging from 0 (None) to 3 (Covering 2/3rd of tooth surface) of the amount of debris or calculus found on the preselected tooth surfaces. The six surfaces examined for the OHI-S are selected from four posterior and two anterior teeth. The buccal surfaces of the selected upper molars and the lingual surfaces of the selected lower molars are inspected. In the anterior portion of the mouth, the labial surfaces of the upper right (11) and the lower left central incisors The average individual or group debris and calculus scores are combined to obtain the Simplified Oral Hygiene Index. The CI-S and DI-S values may range from 0 to 3; the OHI-S values from 0 to 6. Higher scores indicate a worse outcome.
Time Frame
12 months
Title
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.
Description
The Daily Oral Health Checklist will be completed daily by each Caregiver for three days at all three time points in the study. These data will be used to calculate an index to assess Oral Hygiene Practices of residents' use (daily - yes/no) of oral hygiene devices as well as whether adequate time (at least one minute daily) was spent on oral hygiene activities, and whether hygiene activities were completed alone or with caregiver assistance. Dietary practices of persons with IDD will also be measured by the 3-day Daily Oral Health Checklist and completed by Caregivers to assess the frequency and timing of food and beverages that are good and bad for teeth and if caregivers cooperation strategies.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
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