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

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMI and campaigns
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring older adults;, oral hygiene;, adapted motivational interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AMI followed by campaigns

Campaigns followed by AMI

Arm Description

Behavioral interventions

Behavioral interventions

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2015
Last Updated
March 8, 2021
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT02419144
Brief Title
Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health
Official Title
Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
older adults;, oral hygiene;, adapted motivational interviewing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMI followed by campaigns
Arm Type
Active Comparator
Arm Description
Behavioral interventions
Arm Title
Campaigns followed by AMI
Arm Type
Active Comparator
Arm Description
Behavioral interventions
Intervention Type
Behavioral
Intervention Name(s)
AMI and campaigns
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months
Description
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.
Time Frame
pre-intervention, one month, 3 month and 6 month follow-up
Title
Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months
Description
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.
Time Frame
pre-intervention, one month, 3 month and 6 month follow-up
Secondary Outcome Measure Information:
Title
Change in Oral Health Related Quality of Life Change from preintervention, at one month post intervention, 3 months post intervention and 6 months
Description
): 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).
Time Frame
pre-intervention, one month, 3 month and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Reisine, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
34583694
Citation
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.
Results Reference
derived
PubMed Identifier
34289839
Citation
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.
Results Reference
derived
PubMed Identifier
34091935
Citation
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.
Results Reference
derived
PubMed Identifier
33292050
Citation
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.
Results Reference
derived
PubMed Identifier
31850853
Citation
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.
Results Reference
derived

Learn more about this trial

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

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