Efficacy and Efficiency of GEL-AID Gelled Water for Hydration in Institutionalized Older People
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Daily fluid intake
研究概览
简要总结
The objective of this clinical trial is to assess whether hydration with gelled water (GEL-AID) can improve fluid intake and reduce cases of dehydration, as well as the incidence of urinary and respiratory infections in institutionalized elderly individuals in nursing homes.
The main question this trial aims to answer is:
• Do institutionalized elderly individuals hydrated with GEL-AID increase their daily fluid intake and reduce the incidence of dehydration, urinary infections, and respiratory infections?
Participants:
The control group will follow the center's usual hydration plan. Individuals with swallowing difficulties will receive thickened liquids and/or gelatin, while those without swallowing difficulties will be hydrated with unmodified liquids or gelatin.
The intervention group will receive hydration with GEL-AID. For participants with swallowing difficulties, thickened liquids and gelatin will be replaced by GEL-AID, with texture adapted to their needs. Those without swallowing difficulties will receive unmodified liquids and GEL-AID instead of gelatin.
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
- None
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 equal to or greater than 65 years.
排除标准
- •No exclusion criteria have been established.
研究组 & 干预措施
Intervention group
The intervention group will receive hydration with GEL-AID.
干预措施: GEL-AID (Device)
Control Group
The control group will follow the center's standard hydration plan.
干预措施: Usual Care (Other)
结局指标
主要结局
Daily fluid intake
时间窗: From enrollment to the end of intervention at 12 months.
Amount in millilitres (ml)
Dehydration: Serum osmolality
时间窗: Baseline and 3, 6 and 12 months
\[1,86\*(Na+K)+1,15\*Glucose+urea+14)\] Risk dehydration ≥295 mOsm/kg Dehydration \> 300mOsm/kg
Dehydration: Blood Urea Nitrogen (BUN)
时间窗: Baseline and 3, 6 and 12 months
BUN = Urea/2.1428 Dehydration \> 20mg/dl
Number of urinary infections
时间窗: Baseline and 3, 6 and 12 months.
Data will be obtained through retrospective review of the clinical history
Number of respiratory infections
时间窗: Baseline and 3, 6 and 12 months.
Data will be obtained through retrospective review of the clinical history.
Mortality
时间窗: Baseline and 3, 6 and 12 months.
The number of people who will die during the study, as will be obtained from the clinical history.
次要结局
- Current Medical Conditions(Baseline and 3, 6 and 12 months.)
- Pharmacological treatment(Baseline and 3, 6 and 12 months.)
- Laboratory analyses(Baseline and 3, 6 and 12 months)
- Efficacy and safety of swallowing(Baseline and 3, 6 and 12 months.)
- Nutritional status(Baseline and 3, 6 and 12 months.)
- Presence of lesions(Baseline and 3, 6 and 12 months.)
- Presence of edema(Baseline and 3, 6 and 12 months.)
- Dry skin(Baseline and 3, 6 and 12 months.)
- Cognitive status: Mini Cognitive Examination (MEC)(Baseline and 3, 6 and 12 months.)
- Cognitive status: Global Deterioration Scale (GDS)(Baseline and 3, 6 and 12 months.)
- Functional status(Baseline and 3, 6 and 12 months.)
研究者
Teresa Botigué Satorra
Doctor of Health
Universitat de Lleida