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Not yet recruiting NCT07381881

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

No phase Interventional Dehydration Urinary Infections Respiratory Infections Daily Fluid Intake

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GEL-AID, Usual Care.
Who it may be relevant to
Registry conditions: Dehydration, Urinary Infections, Respiratory Infections, Daily Fluid Intake. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Efficiency of GEL-AID Gelled Water for Hydration in Institutionalized Older People

Overview

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.

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.

Primary outcome measures

  • Daily fluid intake [Time frame: From enrollment to the end of intervention at 12 months.]
  • Dehydration: Serum osmolality [Time frame: Baseline and 3, 6 and 12 months]
  • Dehydration: Blood Urea Nitrogen (BUN) [Time frame: Baseline and 3, 6 and 12 months]
  • Number of urinary infections [Time frame: Baseline and 3, 6 and 12 months.]
  • Number of respiratory infections [Time frame: Baseline and 3, 6 and 12 months.]
  • Mortality [Time frame: Baseline and 3, 6 and 12 months.]
Secondary outcome measures (11)
  • Current Medical Conditions [Time frame: Baseline and 3, 6 and 12 months.]
  • Pharmacological treatment [Time frame: Baseline and 3, 6 and 12 months.]
  • Laboratory analyses [Time frame: Baseline and 3, 6 and 12 months]
  • Efficacy and safety of swallowing [Time frame: Baseline and 3, 6 and 12 months.]
  • Nutritional status [Time frame: Baseline and 3, 6 and 12 months.]
  • Presence of lesions [Time frame: Baseline and 3, 6 and 12 months.]
  • Presence of edema [Time frame: Baseline and 3, 6 and 12 months.]
  • Dry skin [Time frame: Baseline and 3, 6 and 12 months.]
  • Cognitive status: Mini Cognitive Examination (MEC) [Time frame: Baseline and 3, 6 and 12 months.]
  • Cognitive status: Global Deterioration Scale (GDS) [Time frame: Baseline and 3, 6 and 12 months.]
  • Functional status [Time frame: Baseline and 3, 6 and 12 months.]

Eligibility criteria

Inclusion criteria

  • Age equal to or greater than 65 years.

Exclusion criteria

  • No exclusion criteria have been established.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Residència per a la Gent Gran Lleida-Balàfia i Residència i Centre de Dia per a la Gent Gr — Lleida

Identifiers

NCT: NCT07381881 · PI24/00413

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗