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| ID | Type | Description | Link |
|---|---|---|---|
| 2023 CLIMA 00047 | Other Grant/Funding Number | Agency for Management of University and Research Grants |
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| Name | Class |
|---|---|
| Agency for Management of University and Research Grants (Catalonia, Spain) | UNKNOWN |
| Hospital Universitari Santa Maria, Spain | OTHER |
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The aim of this clinical trial is to evaluate the effectiveness of a hydration educational program executed through a robot in comparison with the usual hydration program in terms of fluid intake and general health status of the residents. The main question to be answered is whether the use of robotics through a humanoid robot increases the hydration of institutionalized older people.
Participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group will receive a hydration plan executed by a humanoid robot. Healthcare personnel will receive reminders from the robot to record fluid intake through it. |
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| Control group with | Active Comparator | The control group will receive the center's usual hydration plan. The health personnel will make the fluid intake record in paper format and at the end of the shift, as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| humanoid robot | Device | The humanoid robot will execute an educational hydration plan that will be integrated into the usual dynamics of the residence. In order to increase the fluid intake of the residents, stimulation activities will be proposed that will be carried out by the robot such as reminders, interactive activities and positive reinforcement. It will also allow the daily recording fluid intake of each residents. This intervention will last two months. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily fluid intake | Amount in milliliters (ml) | From enrollment to the end of intervention at 8 weeks |
| Urine color | Urine color chart (Armstrong, 2000). Values = 1 - 8. Dehydration: scores >= 4 | 8 weeks |
| Serum osmolarity | Serum osmolarity: [1,86*(Na+K)+1,15*Glucose+urea+14)]. Dehydration > 300mOsm/kg | 8 weeks |
| Blood Urea Nitrogen | BUN = Urea/2.1428. Dehydration > 20mg/dl | 8 weeks |
| Number of urinary infections | Obtained through a urine sample and evaluated with the Combur-Test. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dry Skin | Skin turgor: if skin remains elevated after being pulled up and released | 8 weeks |
| Cognitive status | The Mini Cognitive Examination (MEC) (Values = 0 - 30). Cognitive impairment: scores <= 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Education level | Choose between: no studies, primary studies, secondary studies and university studies. | Baseline |
| Birthdate | Date of birth in yyyy/mm/dd format |
Inclusion Criteria:
No exclusion criteria have been established.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Residència i Centre de Dia per a Gent Gran Balàfia II | Lleida | Lleida | 25005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33593070 | Background | Botigue T, Miranda J, Escobar-Bravo MA, Lavedan A, Roca J, Masot O. [Analysis of dehydration in older people in a nursing home in Spain: prevalence and associated factors]. Nutr Hosp. 2021 Apr 19;38(2):252-259. doi: 10.20960/nh.03260. Spanish. | |
| 33158071 | Background | Masot O, Miranda J, Santamaria AL, Paraiso Pueyo E, Pascual A, Botigue T. Fluid Intake Recommendation Considering the Physiological Adaptations of Adults Over 65 Years: A Critical Review. Nutrients. 2020 Nov 4;12(11):3383. doi: 10.3390/nu12113383. |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Usual care | Other | The center's usual hydration plan |
|
| 8 weeks |
| Cognitive status | Global Deterioration Scale (GDS). Values = 1 - 7. Dementia: scores >= 3 | 8 weeks |
| Risk of falls | Downton scale. Values = 0 - 11. Risk of falls: scores > 2 | 8 weeks |
| Illnesses | Diseases that the participant currently presents | 8 weeks |
| Pharmacological treatment | Number of medicines taken by the participant per day and type of medicine. | 8 weeks |
| Efficacy and safety of swallowing | Volume-Viscosity swallow test (V-VST): identify clinical signs of impaired efficacy (labial seal, oral and pharyngeal residue, and piecemeal deglutition) and impaired safety of swallow (voice changes, cough and decrease in oxygen saturation ≥3%). It starts with nectar viscosity and increasing bolus volume, then liquid and finally pudding viscosity | 8 weeks |
| Nutritional status | Assessed through the Mini Nutritional Assessment (MNA). Values = 0 - 30. Malnutrition: scores < 17 | 8 weeks |
| Risk of pressure ulcers | Braden Scale. Values = 6 - 23. Risk of pressure ulcers: scores < 19 | 8 weeks |
| Functional status | Barthel index. Values = 0 - 100. Functional impairment: scores < 90 | 8 weeks |
| Hospital admissions | Number of hospital admissions | 8 weeks |
| Baseline |
| Marital status | The answer options are: single, married, in partnership (but not married), separated or divorced (currently without a partner), widow (If the answer is "yes"must be specified if less than one year or not). | Baseline |
| Date of institutionalization | Date in yyyy/mm/dd format when the resident began to be institutionalized in the center. | Baseline |
| Sex | Female or male sex | Baseline |
| 30337227 | Background | Botigue T, Masot O, Miranda J, Nuin C, Viladrosa M, Lavedan A, Zwakhalen S. Prevalence and Risk Factors Associated With Low Fluid Intake in Institutionalized Older Residents. J Am Med Dir Assoc. 2019 Mar;20(3):317-322. doi: 10.1016/j.jamda.2018.08.011. Epub 2018 Oct 15. |
| 30525860 | Background | Masot O, Iglesias Millan A, Nuin C, Miranda J, Lavedan A, Botigue T. [How to improve hydration and fluid intake in institutionalized older people? A scientific literature review]. Nutr Hosp. 2018 Dec 3;35(6):1441-1449. doi: 10.20960/nh.1885. Spanish. |
| 29626702 | Background | Masot O, Lavedan A, Nuin C, Escobar-Bravo MA, Miranda J, Botigue T. Risk factors associated with dehydration in older people living in nursing homes: Scoping review. Int J Nurs Stud. 2018 Jun;82:90-98. doi: 10.1016/j.ijnurstu.2018.03.020. Epub 2018 Mar 27. |
| D013568 | Pathological Conditions, Signs and Symptoms |