GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversitat de Lleida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age equal to or greater than 65 years.
Disqualifiers
No exclusion criteria have been established.
Trial design
Design model
Parallel
Treatments tested in this trial
GEL-AID
DeviceFor 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.
Usual Care
Other interventionStandard 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.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Daily fluid intake
Amount in millilitres (ml)
Time frame
From enrollment to the end of intervention at 12 months.2
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 months3
Dehydration: Blood Urea Nitrogen (BUN)
BUN = Urea/2.1428 Dehydration \> 20mg/dl
Time frame
Baseline and 3, 6 and 12 months4
Number of urinary infections
Data will be obtained through retrospective review of the clinical history
Time frame
Baseline and 3, 6 and 12 months.Secondary outcomes
1
Current Medical Conditions
Medical conditions that the participant currently has.
Time frame
Baseline and 3, 6 and 12 months.2
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.3
Laboratory analyses
Blood biochemistry and urinalysis using Combur-Test®
Time frame
Baseline and 3, 6 and 12 months4
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.Other outcomes
1
Birthdate
Date of birth in yyyy/mm/dd
Time frame
Baseline2
Sex
Female or male sex
Time frame
Baseline3
Marital status
The answer options are: single, married, in partnership (but not married), separated or divorced (currently without a partner), and wido. If the answer is "widowed," it must be specified whether the loss occurred less than one year ago or more than one year ago.
Time frame
Baseline4
Education level
Choose between no formal education, primary education, secondary education, or university education.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitat de Lleida
Lead sponsor
Institut de Recerca Biomèdica de Lleida
Collaborator
Hospital Universitari Santa Maria, Spain
Collaborator
Source ClinicalTrials.gov
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