Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-07-31

Brief Summary

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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:

1. 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
2. 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
3. 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
4. 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.

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Detailed Description

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AMI followed by campaigns

Behavioral interventions

Group Type ACTIVE_COMPARATOR

AMI and campaigns

Intervention Type BEHAVIORAL

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.

Campaigns followed by AMI

Behavioral interventions

Group Type ACTIVE_COMPARATOR

AMI and campaigns

Intervention Type BEHAVIORAL

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.

Interventions

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AMI and campaigns

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Permanent residence in sample buildings;
3. Independent of conservator;
4. Must be able to speak English or Spanish;
5. Judged competent to participate (based on ability to respond correctly to key questions about information covered during administration of informed consent.
6. Have two or more remaining natural teeth.

Exclusion Criteria

1. Considered by research staff to be cognitively unable to give informed consent;
2. Exhibition of continued disruptive behavior while participating in the project;
3. 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
4. under conservatorship
5. fewer than two natural teeth

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes