GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults

Universitat de Lleida

Status: Begins enrollment this month

Conditions: Mortality; Urinary Infections; Dehydration; Respiratory Infections; Daily Fluid Intake

Treatments: Device: GEL-AID; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07381881

PI24/00413

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age equal to or greater than 65 years.

Exclusion criteria

• No exclusion criteria have been established.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will receive hydration with GEL-AID.

Treatment:

Device: GEL-AID

Control Group

Active Comparator group

Description:

The control group will follow the center's standard hydration plan.

Treatment:

Other: Usual Care