Evaluation of a Minimal-massive Intervention in Elderly Hospitalized Patients With Oropharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Reduction of incidence of respiratory infections due to the intervention.
研究概览
简要总结
The purpose of this study is to apply a minimal-massive intervention (minimal recommendations to maximal number of patients) to elderly (>70 years) hospitalized patients with oropharyngeal dysphagia (OD). The intervention will consist of early screening and assessment of OD, malnutrition and oral hygiene. Patients will be given recommendations for adaptation of volume and viscosity of fluids, nutritional support and good oral hygiene practices and followed at 3, 6, 9 and 12 months after discharge. In every point of the follow-up period, patients will be re-evaluated to adjust recommendations and to verify their compliance with the treatment.
The objectives of the intervention are to have an impact on complications related to OD (avoid impaired safety alterations and improve nutritional and oral health status and reduce) and to reduce readmissions, readmissions for pneumonia and morbimortality.
详细描述
These study aims to evaluate the application of an assistance programme to:
- Perform a systematic screening of oropharyngeal dysphagia in older hospitalized patients (≥70 yr) admitted to internal medicine and geriatric unit of Hospital de Mataró.
- Offer a minimal-massive treatment to older patients with OD based on, rheological adaptation of fluids (volume and viscosity), nutritional support based on traditional diet and oral hygiene treatment.
- To give education and knowledge about the diagnose and treatment of OD to the medical staff, caregivers and relatives of the patients to improve their management.
Study design:
Experimental pre-post interventional study with 1 year follow-up and 4 control points at 3, 6, 9 and 12 months after discharge. Pre-interventional evaluations will be done on admission and at discharge; post-interventional evaluations will be performed at 3, 6, 9 and 12 months after discharge. In every evaluation point the investigators will obtain data about OD (efficacy and safety of swallow with the Volume-Viscosity Swallowing Test (V-VST)), health status of the patients (comorbidities, functionality, frailty, anthropometric measurements, illnesses and medication), nutritional status (MNA-sf and Bioimpedance), oral hygiene (dental evaluation with the Simplified Oral Hygiene Index (OHI-S)) and respiratory infections and pneumonia rates. In addition during the follow-up period the investigators will collect readmissions incidence (all readmissions, respiratory infections and pneumonia), institutionalization and death. Data collected will be compared with the previous year of the same patient and with a historical control group of untreated older patients with OD that will be matched for age, sex, comorbidities and functionality.
The intervention will consist on adaptation of fluids (volume and viscosity) in accordance with V-VST results, nutritional supplementation with traditional food (based on MNA-sf and bioimpedance results) and recommendation of good oral hygiene practices (based on dental evaluation). In every point of the follow-up period, recommendations will be given to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Older patients (≥70 years) admitted to Unit 5 and 8 of Hospital de Mataró.
- •With OD diagnosed by the V-VST.
- •Patients that have signed the informed consent form.
- •Patients without any
排除标准
- •Exclusion Criteria:
- •Patients not able to comply with the protocol.
- •Patients currently participating in any clinical trial or during the 4 last weeks.
- •Patients with severe dementia or inability to communicate (GDS ≥ 6).
- •Patients of the Intensive Care Unit.
- •Patients with low functionality (Barthel pre-admission ≤ 40).
- •Patients with high mortality risk (Walter score > 6).
研究组 & 干预措施
Minimal-Massive Intervention
The minimal/basic intervention for a massive number of hospitalized patients.
干预措施: Minimal-Massive Intervention (Other)
结局指标
主要结局
Reduction of incidence of respiratory infections due to the intervention.
时间窗: One year after discharge
Readmissions for respiratory infections (including pneumonia) will be recorded and compared with the previous year of the same patient (pre-post study) and with a retrospective control group of elderly patients with dysphagia without intervention. Review of the medical history of the patient will be done by a medical doctor. Follow-up visits will be done every three months for a total of 12 months.
次要结局
- Improvement of signs and symptoms of oropharyngeal dysphagia(One year after discharge)
- Improvement of nutritional status of the patients enrolled.(One year after discharge)
- Improvement of oral health and hygiene of the patients enrolled.(One year after discharge)
- Improvement of quality of life of patients enrolled.(One year after discharge)
研究者
Pere Clave
PhD. MD surgery.
Hospital de Mataró