Effect of an Oral Frailty Measures Program in Institutionalized Elders: a Study Protocol of a Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Assessing changes in the risk of oral frailty
研究概览
简要总结
This is a compelling 16-week prospective, double-blind, whole-cluster randomized controlled trial(RCT).This study will recruit 226 older adults over the age of 65.Based on King's goal attainment theory, a program to promote oral health is developed.The study aims to evaluate the effectiveness of a mixed face-to-face and eHealth oral health promotion program for older adults with oral frailty in nursing homes, based on the Theory of Planned Behavior.
详细描述
Background:
Oral frailty is a progressive loss of oral function associated with aging, usually caused by a variety of injuries. Some recent studies have shown that oral frailty is closely linked to physical functioning (physical frailty and changes in body composition), as well as nutritional status (low protein intake, poor dietary diversity, and malnutrition) in older adults in addition, a significant association between inadequate social network participation and poor oral function has also been confirmed by research. Oral frailty in older adults not only decreases their quality of life but also leads to serious problems like cognitive impairment, falls, disability, and even death. This puts a strain on families and society in terms of healthcare. Early Identifying and treating oral frailty is important for improving the quality of life of older adults and reducing the pressure on healthcare resources.
Aim:
The researchers hypothesize that a health program based on King's goal achievement theory will have a significant effect on oral frailty among older adults in nursing homes. Therefore, in this study, researchers will explore the impact of a health program based on King's goal achievement theory on oral frailty in older adults residing in nursing homes.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The first author will use randomizer.org for randomization. Recruitment without informing the subjects of study participation and group allocation to blind the subjects. And the allocation is also concealed for researchers in charge of data collection and processing.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years old
- •Residing in a nursing home for ≥ 3 months
- •Meeting at least three of the six criteria for oral frailty
- •Conscious and with normal reading and comprehension abilities
- •Informed consent to participate in this study
排除标准
- •Edentulous state without dentures
- •Cognitive or communication impairments
- •Elderly lacking self-care ability
结局指标
主要结局
Assessing changes in the risk of oral frailty
时间窗: Before and 16 weeks after the intervention
Oral frailty risk was assessed using the Chinese version of the Oral Frailty Index-8 (OFI-8 scale) translated by zongme.The scale consists of eight items with a total score ranging from 0 to 11, with higher scores indicating poorer oral health and higher risk of oral frailty. These include healthy (0-2 points), pre oral debilitation (3 points), oral debilitation (4-6 points) and severe oral debilitation (≥7 points).
Assessing changes in oral function status
时间窗: Before and 16 weeks after the intervention
We will use the Oral Frailty Assessment Instrument (OFI) created by Tanaka to measure the presence or absence of oral frailty and the detailed status of oral functioning to provide a basis for targeted interventions at a later stage. An assessment was made based on 6 items in the method described by Tanaka et al. These included the number of teeth, mastectomy function, articulation skills, tongue pressure, subjective feeding, and swallowing difficulty or not. Oral fragility was considered exist if at least 3 of the criteria were met. These included (1) Lower number of remaining teeth;(2) mastectomy score; (3) oral motor skills; (4) tongue pressure; (5) eating hard foods with subjective difficulty (yes); and (6) subjective dysphagia (yes). We used the Kihon questionnaire to ask about any difficulties with eating hard food and swallowing.
次要结局
- Assessment of changes in body composition(Before and 16 weeks after the intervention)
- Nutrition Screening(Before and 16 weeks after the intervention)
- Changes in Social Support(Before and 16 weeks after the intervention)
- Self Efficacy(Before and 16 weeks after the intervention)
- Changes in frailty(Before and 16 weeks after the intervention)
研究者
HangTian Zhu
Principal Investigator
Hangzhou Normal University