GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults
NCT07381881 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2026-02-02
Summary
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.
Conditions
- Dehydration
- Urinary Infections
- Respiratory Infections
- Daily Fluid Intake
- Mortality
Interventions
- DEVICE
-
GEL-AID
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.
- OTHER
-
Usual Care
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.
Sponsors & Collaborators
-
Institut de Recerca Biomèdica de Lleida
collaborator OTHER -
Hospital Universitari de Santa María (Lleida - Spain).
collaborator UNKNOWN -
Universitat de Lleida
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-23
- Primary Completion
- 2027-02-28
- Completion
- 2027-12-31
Countries
- Spain
Study Locations
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