Oral HealthOHPROMNCT03834064
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
A study testing Oral health promotion strategy in people with Oral Health, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Oral health promotion strategy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
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.
Read the 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).
- Conditions
- Oral Health
- Being tested
- Oral health promotion strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health promotion strategyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Oral health promotion strategy |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 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.
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
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Jun 2018
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Himabindu Dukka, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834064
- Sponsor's protocol ID
- 16020E
- Other IDs
- U01DE025833
- Acronym
- OHPROM
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2019
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
- ClinicalTrials.gov ID
- NCT03834064
- Acronym / sponsor ID
- OHPROM / 16020E
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Oral health promotion strategyHomes 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Persons with IDD: To be eligible to participate in this study, an individual must meet all of the following criteria:
- 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
Key exclusion criteria (2 listed)
- Persons with IDD: Will be excluded (screen failure) if they are unable to cooperate or refuse the oral examination.
- Caregivers: There are no exclusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral health promotion strategyThe 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). | Behavioural | Intervention |
Primary outcome
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.
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral health promotion strategy in people with Oral Health, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.