Farmington, Connecticut 06030


Purpose:

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.


Criteria:

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, joint replacement surgery. 4. under conservatorship 5. fewer than two natural teeth


NCT ID:

NCT02419144


Primary Contact:

Principal Investigator
Susan Reisine, PhD
UConn Health

Susan Reisine, OhD
Phone: 8606793823
Email: reisine@uchc.edu


Backup Contact:

Email: Jean.Schensul@icrweb.org
Jean J Schensul, PhD
Phone: Phone: 860-278-2044


Location Contact:

Farmington, Connecticut 06030
United States

Susan Reisine, PhD
Phone: 860-679-3823
Email: reisine@nso1.uchc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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