- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834064
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities (OHPROM)
October 13, 2023 updated by: Himabindu Dukka, University of Louisville
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
412
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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).
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 12 months
|
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.
|
12 months
|
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.
Time Frame: 12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in caregiver self-efficacy from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Time Frame: 12 months
|
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.
|
12 months
|
Change in caregiver outcome expectancies from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Time Frame: 12 months
|
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
|
12 months
|
Change in caregiver behavioral capability from baseline to 4 months and 12 months in the experimental group compared to the control group of caregivers.
Time Frame: 12 months
|
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.
|
12 months
|
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.
Time Frame: 12 months
|
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.
|
12 months
|
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.
Time Frame: 12 months
|
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.
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12 months
|
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.
Time Frame: 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.
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
November 30, 2021
Study Completion (Actual)
November 30, 2021
Study Registration Dates
First Submitted
January 24, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (Actual)
February 7, 2019
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16020E
- U01DE025833 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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