Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria Among Middle-aged and Elderly Hospitalized Adults With Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- oral frailty measures
研究概览
简要总结
The aim of this study is to examine the effectiveness of nurse-driven oral management for improvements of oral frailty, and oral bacteria pneumonia patients with oral frailty using a randomized controlled trial (RCT) design. Hospitalized pneumonia patients (N = 90) will be randomized into three groups (oral management, oral care, and standard of care). The primary outcomes include the oral frailty measures determined by seven-item included oral hygiene, oral dryness, occlusion force, tongue-lip motor function, tongue pressure, mastication function, and swallowing function. Saliva samples were collected from the oral cavity before the bacterial culture was performed in the laboratory. Oral frailty measures and the presence of bacterial exposure were evaluated at baseline (1st day), on days 5, and at the time of discharge. The investigators will perform statistical analyses according to the intention-to-treat principle. All missing values will be imputed using the last value carry-forward method. The between-group differences will be examined using a mixed model in which group and time interaction will be included. This study finding could provide oral management strategies that could improve oral frailty and decrease oral bacteria for preventing recurrent pneumonia infection among middle-aged and older adults with pneumonia.
详细描述
The inclusion criteria will be as follows: (1) patients should be ≥ 50 years old; (2) patients' oral frailty should have been diagnosed with pneumonia, and (3) patients should have a Glasgow coma index of 15 points and be able to cooperate. Alternatively, the exclusion criteria will be as follows: (1) people with healthcare-related pneumonia; (2) those with head and neck cancer; or (3) those having an abnormal oral structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 50 years of age and equal
- •Having mental clarity (Glasgow coma scale: 15)
排除标准
- •A brief hospitalization (≤ 3 days) for non-acute care, such as uncomplicated elective percutaneous coronary intervention;
- •Acute psychiatric syndromes;
- •Received dental treatment in the last 6 months.
结局指标
主要结局
oral frailty measures
时间窗: Discharge day
The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
Clearance of pneumonia associated oral bacteria
时间窗: Discharge day
The investigators collected participants' gargling water for bacterial isolation and identification. The investigators asked the participant to gargle with 20 ml of N/S for approximately 20 seconds. The standard procedure for gargling was full mouth at least three times. The investigators collected gargling water in a bacterial collection bottle and sent it for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation due to the different rinse solutions, the number of bacteria was determined again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
次要结局
未报告次要终点
研究者
Chen, Yen-Chin
Vice Head Nurse and Clinical Assistant Professor
National Cheng-Kung University Hospital