Evaluation of the Effectiveness of an Optimal-Massive Intervention in Older Patients With Oropharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Respiratory infections incidence.
研究概览
简要总结
The aim of this study is to evaluate the efficacy of an optimal-massive intervention (OMI) based on increasing shear viscosity of fluids, nutritional support with oral nutritional supplements (ONS) and triple adaptation of food (rheological and textural, caloric and protein and organoleptic) and oral hygiene improvement on the incidence of respiratory infections in older patients with OD. We have designed a randomized clinical trial, with two parallel arms and 6 months follow-up. The study population will be constituted by older patients of 70 years or more with OD hospitalized at Hospital de Mataró by an acute process that will be identified by using the volume-viscosity swallow clinical test. We will consecutively recruit 500 subjects during admission (Geriatrics, Internal medicine, etc.) at the Hospital de Mataró. Patients included will be randomly assigned to one of both interventional groups: a) study intervention: multifactorial intervention based on fluid viscosity adaptation (with a xanthan gum thickener -> Nutilis Clear®), nutritional support with a triple adaptation of food (texture, caloric and protein content, organoleptic) + pre-thickened ONS and evaluation and treatment of oral hygiene (tooth brushing + antiseptic mouthwashes + professional dental cleaning), or b) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder and simple texture adaptation for solids). Main outcome measures: respiratory infection incidence during the 6-month period follow-up. Secondary outcomes: mortality at 6 months, general hospital readmissions and readmissions due to respiratory infections, nutritional status, hydration status, quality of life, functional status, oral hygiene and dysphagia severity and its relationship with other study variables.
详细描述
DESIGN
- Study design: Randomized controlled clinical trial with two parallel arms and 6 months follow-up.
AIMS
- Primary aim: To evaluate the effect of a rheological, nutritional and oral hygiene intervention (OMI) on the incidence of respiratory infections including lower respiratory tract infections -LRTI-, pneumonia and chronic obstructive pulmonary disease (COPD) infectious exacerbations in older patients with OD at 6 months follow-up.
- Secondary aims: to evaluate the effect at 1, 3 and 6 months of this intervention on:
- Mortality.
- General hospital readmission and hospital readmission due to respiratory infections.
- Nutritional status according to the MNA, anthropometrical measures and biochemical markers.
- Hydration status according to bioimpedance.
- Quality of life according to the EQ-5D.
- Functional status according to Barthel index.
- Oral hygiene status according to the simplified oral hygiene index (OHI-S).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 70 years or older.
- •Diagnosed oropharyngeal dysphagia (signs of impaired efficacy and/or safety of swallow assessed with the V-VST).
- •Giving written informed consent. In case of dementia or incapacitation, given consent by the nearest relative, main caregiver or legal representative.
排除标准
- •Impaired safety of swallow with 5mL at high viscosity (800 mPa•s for NC).
- •Severe dementia (Pfeiffer >6).
- •Life expectancy less than 6 months.
- •High functional dependence (Barthel index <40, preadmission).
- •Dysphagia caused by anatomical alterations or by head and neck cancer or its treatment.
- •Patients going to nursing home or long-term care at discharge.
- •Participation in any other studies involving investigational or marketed products within four weeks prior to start of the study.
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- •Patients with symptoms suggestive of COVID-19 or confirmed COVID-19.
结局指标
主要结局
Respiratory infections incidence.
时间窗: From discharge to 6 months follow-up
Respiratory infections incidence (includes LRTI, pneumonia and exacerbations of COPD): all new episodes of respiratory infections recorded in the clinical history or in the reports presented by the patient will be recorded. LRTI: presence of at least 2 of the following symptoms without other cause to explain them: fever, cough, purulent expectoration, rhonchi or wheezing. Pneumonia: performing 1 or more radiographic tests with new condensation, fever or leukopenia or leukocytosis and at least: cough, purulent expectoration, dyspnea, tachypnea, suggestive auscultation or worsening of gas exchange. COPD exacerbation: acute exacerbation of COPD is a sudden worsening of COPD symptoms (shortness of breath, quantity and color of phlegm) that typically lasts for several days. It may be triggered by an infection with bacteria or viruses or by environmental pollutants.
次要结局
- Nutritional status (Anthropometric measures2)(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Nutritional status (Anthropometric measures)(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Mortality(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Nutritional status (MNA)(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Quality of life of patients during the study period(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Functional status(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- General readmissions and readmissions for respiratory infections(Through study completion, at 1, 3 and 6 months from disharge.)
- Nutritional status (Biochemical parameters)(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Hydration status (bioimpedance)(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Oral Hygiene(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
- Dysphagia severity(Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.)
研究者
Pere Clave
Director of Research and Academic Development at CSdM
Hospital de Mataró