Good Oral Health - A Bi-level Intervention to Improve Older Adult Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Gingival Index from preintervention, at one month post intervention, 3 months post intervention and 6 months
时间窗: pre-intervention, one month, 3 month and 6 month follow-up
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.
Change in Plaque scores from preintervention, at one month post intervention, 3 months post intervention and 6 months
时间窗: pre-intervention, one month, 3 month and 6 month follow-up
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.
次要结局
- 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)
研究者
Susan Reisine
Professor Emeritus
UConn Health