Daily Fluid Intake, Dehydration, Mortality, Respiratory Infections, Urinary Infections
Conditions
Keywords
dehydration, aged, nursing homes, fluid intake, gelled water
Brief 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.
Interventions
DEVICEGEL-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.
OTHERUsual 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
Universitat de Lleida
Institut de Recerca Biomèdica de Lleida
Hospital Universitari de Santa María (Lleida - Spain).
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age equal to or greater than 65 years.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily fluid intake | From enrollment to the end of intervention at 12 months. | Amount in millilitres (ml) |
| Dehydration: Serum osmolality | Baseline and 3, 6 and 12 months | \[1,86\*(Na+K)+1,15\*Glucose+urea+14)\] Risk dehydration ≥295 mOsm/kg Dehydration \> 300mOsm/kg |
| Dehydration: Blood Urea Nitrogen (BUN) | Baseline and 3, 6 and 12 months | BUN = Urea/2.1428 Dehydration \> 20mg/dl |
| Number of urinary infections | Baseline and 3, 6 and 12 months. | Data will be obtained through retrospective review of the clinical history |
| Number of respiratory infections | Baseline and 3, 6 and 12 months. | Data will be obtained through retrospective review of the clinical history. |
| Mortality | Baseline and 3, 6 and 12 months. | The number of people who will die during the study, as will be obtained from the clinical history. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Current Medical Conditions | Baseline and 3, 6 and 12 months. | Medical conditions that the participant currently has. |
| Pharmacological treatment | Baseline and 3, 6 and 12 months. | Number of medications the participant takes per day and the type of each medication. |
| Laboratory analyses | Baseline and 3, 6 and 12 months | Blood biochemistry and urinalysis using Combur-Test® |
| Efficacy and safety of swallowing | Baseline and 3, 6 and 12 months. | 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. |
| Nutritional status | Baseline and 3, 6 and 12 months. | Will be assessed using the Mini Nutritional Assessment (MNA). Scores range from 0 to 30. Malnutrition will be defined as scores \< 17. |
| Presence of lesions | Baseline and 3, 6 and 12 months. | The number and location of lesions. |
| Presence of edema | Baseline and 3, 6 and 12 months. | Yes or no |
| Dry skin | Baseline and 3, 6 and 12 months. | Skin turgor: determining whether the skin remains elevated after being gently pinched and released. |
| Cognitive status: Mini Cognitive Examination (MEC) | Baseline and 3, 6 and 12 months. | Values = 0 - 30. Cognitive impairment: scores \<= 23 |
| Cognitive status: Global Deterioration Scale (GDS) | Baseline and 3, 6 and 12 months. | Values = 1 - 7. Dementia: scores ≥ 3 |
| Functional status | Baseline and 3, 6 and 12 months. | Barthel index. Values = 0 - 100. Functional impairment: scores \< 90 |
Countries
Spain
Contacts
CONTACTDra. Teresa Botigué Satorra
Outcome results
None listed