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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
156
For patients with swallowing difficulties, thickened liquids with commercial thickeners and gelatin will be replaced with the GEL-AID product. The texture provided will depend on the results obtained from the Volume-Viscosity Swallow Test (V-VST). Those without swallowing difficulties will be hydrated with unmodified liquids and will also be offered GEL-AID as a replacement for gelatin.
Standard intervention. For subjects with swallowing difficulties, the hydration method will involve thickened liquids with a commercial thickener (texture adjusted according to the results obtained from the V-VST) and gelatin. Those without swallowing difficulties will be hydrated with unmodified liquids and will also be offered gelatin.
Residència per a la Gent Gran Lleida-Balàfia i Residència i Centre de Dia per a la Gent Gran Balàfia II
Lleida, Lleida, Spain
Daily fluid intake
Amount in millilitres (ml)
Time frame: From enrollment to the end of intervention at 12 months.
Dehydration: Serum osmolality
\[1,86\*(Na+K)+1,15\*Glucose+urea+14)\] Risk dehydration ≥295 mOsm/kg Dehydration \> 300mOsm/kg
Time frame: Baseline and 3, 6 and 12 months
Dehydration: Blood Urea Nitrogen (BUN)
BUN = Urea/2.1428 Dehydration \> 20mg/dl
Time frame: Baseline and 3, 6 and 12 months
Number of urinary infections
Data will be obtained through retrospective review of the clinical history
Time frame: Baseline and 3, 6 and 12 months.
Number of respiratory infections
Data will be obtained through retrospective review of the clinical history.
Time frame: Baseline and 3, 6 and 12 months.
Mortality
The number of people who will die during the study, as will be obtained from the clinical history.
Time frame: Baseline and 3, 6 and 12 months.
Current Medical Conditions
Medical conditions that the participant currently has.
Time frame: Baseline and 3, 6 and 12 months.
Pharmacological treatment
Number of medications the participant takes per day and the type of each medication.
Time frame: Baseline and 3, 6 and 12 months.
Laboratory analyses
Blood biochemistry and urinalysis using Combur-Test®
Time frame: Baseline and 3, 6 and 12 months
Efficacy and safety of swallowing
Volume-Viscosity Swallow Test (V-VST): identify clinical signs of impaired efficacy (labial seal impairment, oral and pharyngeal residue, and piecemeal deglutition) and impaired safety of swallowing (voice changes, coughing, and a decrease in oxygen saturation ≥3%). It begins with nectar viscosity and progressively increases the bolus volume, then proceeds to liquid, and finally to pudding viscosity.
Time frame: Baseline and 3, 6 and 12 months.
Nutritional status
Will be assessed using the Mini Nutritional Assessment (MNA). Scores range from 0 to 30. Malnutrition will be defined as scores \< 17.
Time frame: Baseline and 3, 6 and 12 months.
Presence of lesions
The number and location of lesions.
Time frame: Baseline and 3, 6 and 12 months.
Presence of edema
Yes or no
Time frame: Baseline and 3, 6 and 12 months.
Dry skin
Skin turgor: determining whether the skin remains elevated after being gently pinched and released.
Time frame: Baseline and 3, 6 and 12 months.
Cognitive status: Mini Cognitive Examination (MEC)
Values = 0 - 30. Cognitive impairment: scores \<= 23
Time frame: Baseline and 3, 6 and 12 months.
Cognitive status: Global Deterioration Scale (GDS)
Values = 1 - 7. Dementia: scores ≥ 3
Time frame: Baseline and 3, 6 and 12 months.
Functional status
Barthel index. Values = 0 - 100. Functional impairment: scores \< 90
Time frame: Baseline and 3, 6 and 12 months.
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