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

NCT02419144 | Completed

• 1 other identifier: 14-188-6
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 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.

Conditions

Gingivitis

Keywords

older adults;; oral hygiene;; adapted motivational interviewing

Outcome Measures

Primary Outcomes (2)

• Change in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months

  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.

  pre-intervention, one month, 3 month and 6 month follow-up

• Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months

  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.

  pre-intervention, one month, 3 month and 6 month follow-up

Secondary Outcomes (1)

• Change in Oral Health Related Quality of Life Change from preintervention, at one month post intervention, 3 months post intervention and 6 months

  pre-intervention, one month, 3 month and 6 month follow-up

Study Arms (2)

AMI followed by campaigns

ACTIVE COMPARATOR

Behavioral interventions

Behavioral: AMI and campaigns

Campaigns followed by AMI

ACTIVE COMPARATOR

Behavioral interventions

Behavioral: AMI and campaigns

Interventions

AMI and campaigns 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.

AMI followed by campaigns; Campaigns followed by AMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (5)

• 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.

  PMID: 34583694 DERIVED

• 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.

  PMID: 34289839 DERIVED

• 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.

  PMID: 34091935 DERIVED

• 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.

  PMID: 33292050 DERIVED

• 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.

  PMID: 31850853 DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Susan Reisine, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 17, 2015
• Study Start: May 1, 2015
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)