Clinical trial NCT02419144: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: older adults;
oral hygiene;
adapted motivational interviewing
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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. 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.


Eligibility 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
4. under conservatorship
5. fewer than two natural teeth

Primary outcomes:
measure: Change in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months
timeFrame: pre-intervention, one month, 3 month and 6 month follow-up
measure: Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months
timeFrame: pre-intervention, one month, 3 month and 6 month follow-up
Secondary outcomes:
measure: Change in Oral Health Related Quality of Life Change from preintervention, at one month post intervention, 3 months post intervention and 6 months
timeFrame: pre-intervention, one month, 3 month and 6 month follow-up
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Susan Reisine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.