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| Name | Class |
|---|---|
| Institut de Recerca Biomèdica de Lleida | OTHER |
| Hospital Universitari Santa Maria, Spain | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group will receive hydration with GEL-AID. |
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| Control Group | Active Comparator | The control group will follow the center's standard hydration plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEL-AID | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily fluid intake | Amount in millilitres (ml) | From enrollment to the end of intervention at 12 months. |
| Dehydration: Serum osmolality | [1,86*(Na+K)+1,15*Glucose+urea+14)] Risk dehydration ≥295 mOsm/kg Dehydration > 300mOsm/kg | Baseline and 3, 6 and 12 months |
| Dehydration: Blood Urea Nitrogen (BUN) | BUN = Urea/2.1428 Dehydration > 20mg/dl | Baseline and 3, 6 and 12 months |
| Number of urinary infections | Data will be obtained through retrospective review of the clinical history | Baseline and 3, 6 and 12 months. |
| Number of respiratory infections | Data will be obtained through retrospective review of the clinical history. | Baseline and 3, 6 and 12 months. |
| Mortality | The number of people who will die during the study, as will be obtained from the clinical history. | Baseline and 3, 6 and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Current Medical Conditions | Medical conditions that the participant currently has. | Baseline and 3, 6 and 12 months. |
| Pharmacological treatment | Number of medications the participant takes per day and the type of each medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Birthdate | Date of birth in yyyy/mm/dd | Baseline |
| Sex | Female or male sex | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dra. Teresa Botigué Satorra | Contact | +34 973702458 | teresa.botigue@udl.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Residència per a la Gent Gran Lleida-Balàfia i Residència i Centre de Dia per a la Gent Gran Balàfia II | Lleida | Lleida | 25005 | Spain |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Usual Care | Other | 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. |
|
| Baseline and 3, 6 and 12 months. |
| Laboratory analyses | Blood biochemistry and urinalysis using Combur-Test® | Baseline and 3, 6 and 12 months |
| 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. | Baseline and 3, 6 and 12 months. |
| Nutritional status | Will be assessed using the Mini Nutritional Assessment (MNA). Scores range from 0 to 30. Malnutrition will be defined as scores < 17. | Baseline and 3, 6 and 12 months. |
| Presence of lesions | The number and location of lesions. | Baseline and 3, 6 and 12 months. |
| Presence of edema | Yes or no | Baseline and 3, 6 and 12 months. |
| Dry skin | Skin turgor: determining whether the skin remains elevated after being gently pinched and released. | Baseline and 3, 6 and 12 months. |
| Cognitive status: Mini Cognitive Examination (MEC) | Values = 0 - 30. Cognitive impairment: scores <= 23 | Baseline and 3, 6 and 12 months. |
| Cognitive status: Global Deterioration Scale (GDS) | Values = 1 - 7. Dementia: scores ≥ 3 | Baseline and 3, 6 and 12 months. |
| Functional status | Barthel index. Values = 0 - 100. Functional impairment: scores < 90 | Baseline and 3, 6 and 12 months. |
| 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. |
| Baseline |
| Education level | Choose between no formal education, primary education, secondary education, or university education. | Baseline |
| Date of institutionalization | The date (yyyy/mm/dd) when the resident will be recorded as having begun institutionalization at the center. | Baseline |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |