- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02419144
Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health
This study will test an intervention designed to change oral health norms and reduce disparities in oral health among vulnerable adults residing in publicly funded senior housing in Central Connecticut. The intervention model is based on Fishbein modified theory of reasoned action operationalized through Adapted Motivational Interviewing and Practice to Mastery. The intervention includes two components: 1) a face to face administration of the Adapted Motivational Interviewing and Practice to Mastery, a participatory counseling model, and 2) a targeted building level campaign consisting of three half-day oral health events with skills development through practice to mastery to parallel the individual intervention, all based on the study's conceptual model. The study uses a modified fractional factorial design to evaluate the face to face and campaign components separately and in different additive sequences. Six buildings will be paired in three dyads. The buildings in each dyad will be randomized to either having the Adapted Motivational Interviewing and Practice to Mastery intervention first followed by campaigns or to having the campaigns first followed by Adapted Motivational Interviewing and Practice to Mastery. Seventy-five residents will be recruited in each building for a total of 450 participants. There will be four assessments:
- T0 will include a survey, oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. The survey will provide data on the conceptual domains that are the target of the tailored intervention
- T1 will follow the AMI-PM or CA+PM (depending on condition) and will include the survey, oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. This assessment will occur 1-2 months after the initial intervention
- T2 will follow the AMI-PM or CA+PM and will include the survey, oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. This assessment will occur 6 months after the initial intervention
- T3 will include oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque Score. This will occur 15-18 months after study entry. We will use general linear mixed models (GLMM) or general estimating equations (GEE), respectively, to fit a model with intervention and period effects using the MIXED procedure in SAS.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Disabled children and adults aged 18 years and above, and adults 62 and above, including both male and female building residents, and minorities and non-minorities;
- Permanent residence in sample buildings;
- Independent of conservator;
- Must be able to speak English or Spanish;
- Judged competent to participate (based on ability to respond correctly to key questions about information covered during administration of informed consent.
- Have two or more remaining natural teeth.
Exclusion Criteria:
- Considered by research staff to be cognitively unable to give informed consent;
- Exhibition of continued disruptive behavior while participating in the project;
- History of infective endocarditis, prosthetic cardiac valve replacement, insertion of an arterial stent in past 6 months, myocardial infarction (heart attack) in past 6 months
- under conservatorship
- fewer than two natural teeth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: AMI followed by campaigns
Behavioral interventions
|
The intervention we are proposing is a tailored bi-level intervention with two components, an individual level component (component A) with tailored messages based on performance on clinical assessment results, ADLs and cognitive domains in the survey delivered through adapted motivational interviewing with practice to mastery (AMI-PM); , and a building level campaign (component B) for those enrolled in the study (but open to all building residents that includes building tailored messages based on cognitive domains and skills reinforcement through Practice to Mastery.
|
ACTIVE_COMPARATOR: Campaigns followed by AMI
Behavioral interventions
|
The intervention we are proposing is a tailored bi-level intervention with two components, an individual level component (component A) with tailored messages based on performance on clinical assessment results, ADLs and cognitive domains in the survey delivered through adapted motivational interviewing with practice to mastery (AMI-PM); , and a building level campaign (component B) for those enrolled in the study (but open to all building residents that includes building tailored messages based on cognitive domains and skills reinforcement through Practice to Mastery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months
Time Frame: pre-intervention, one month, 3 month and 6 month follow-up
|
We will use a plaque scoring scheme developed by O'Leary (O'Leary, Drake, Naylor, 1972).
This index consists of dichotomous presence or absence scores for plaque on each tooth surface.
The supragingival bacterial plaque will be assessed with the use of erythrosine disclosing solution in six surfaces of each tooth.
The non-toxic vegetable-based solution will be applied to the teeth by the examining hygienist.
The number of surfaces stained red will be calculated over the total number of surfaces and the plaque score will be expressed as a percentage of surfaces with plaque as a ratio.
We used this measure in the pilot study and demonstrated significant reductions in plaque after the intervention.
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pre-intervention, one month, 3 month and 6 month follow-up
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Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months
Time Frame: pre-intervention, one month, 3 month and 6 month follow-up
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The Gingival Index (GI) (Loe & Silness, 1963) will be used to assess the gingival status related to six surfaces of each tooth.
Each surface is scored for gingival inflammation: 0=no visual signs of inflammation; 1=slight change in color and texture of the gingiva but no bleeding; 2=visual sign of inflammation and bleeding upon swiping; 3=overt inflammation and spontaneous bleeding.
The index is calculated by summing each surface GI and dividing by the total number of surfaces (mean value).
Individual scores are summed to obtain a mean.
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pre-intervention, one month, 3 month and 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Oral Health Related Quality of Life Change from preintervention, at one month post intervention, 3 months post intervention and 6 months
Time Frame: pre-intervention, one month, 3 month and 6 month follow-up
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): We will use the General (Geriatric) Oral Health Assessment Inventory (GOHAI), a commonly used 12-item measure initially developed for older adults that has been used with low income populations (Atchison & Dolan, 1990).
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pre-intervention, one month, 3 month and 6 month follow-up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Reisine S, Schensul JJ, Salvi A, Grady J, Ha T, Li J. Oral health-related quality of life outcomes in a randomized clinical trial to assess a community-based oral hygiene intervention among adults living in low-income senior housing. Health Qual Life Outcomes. 2021 Sep 28;19(1):227. doi: 10.1186/s12955-021-01859-w.
- Schensul J, Reisine S, Salvi A, Ha T, Grady J, Li J. Evaluating mechanisms of change in an oral hygiene improvement trial with older adults. BMC Oral Health. 2021 Jul 21;21(1):362. doi: 10.1186/s12903-021-01701-1.
- Reisine S, Schensul JJ, Salvi A, Grady J, Ha T, Li J. Does sequencing matter? A cross-over randomized trial to evaluate a bi-level community-based intervention to improve oral hygiene among vulnerable adults. Community Dent Oral Epidemiol. 2022 Aug;50(4):270-279. doi: 10.1111/cdoe.12663. Epub 2021 Jun 6.
- Schensul JJ, Salvi A, Ha T, Grady J, Li J, Reisine S. Evaluating Cognitive/Emotional and Behavioral Mediators of Oral Health Outcomes in Vulnerable Older Adults. J Appl Gerontol. 2022 Jan;41(1):187-197. doi: 10.1177/0733464820974920. Epub 2020 Dec 8.
- Schensul J, Reisine S, Grady J, Li J. Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health). JMIR Res Protoc. 2019 Dec 18;8(12):e14555. doi: 10.2196/14555.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-188-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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