Robotics as a Useful Tool to Improve the Hydration of the Elderly (Hidroponent)

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:

• The intervention group will receive a hydration plan executed by the robot and the control group will receive the center's usual hydration plan.
• Healthcare personnel will receive reminders from the robot to record fluid intake through it. In the control group, health personnel will perform the fluid intake record in paper format and at the end of the shift, as usual.

Study Overview

• Status: Completed
• Conditions: Dehydration; Urinary Infections; Daily Fluid Intake
• Intervention / Treatment: Device: humanoid robot; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25005
    • Residència i Centre de Dia per a Gent Gran Balàfia II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age equal to or greater than 65 years.

No exclusion criteria have been established.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Device: humanoid robot; 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.
Active Comparator: Control group with; 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.	Other: Usual care; The center's usual hydration plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universitat de Lleida
• Collaborators: Agency for Management of University and Research Grants (Catalonia, Spain); Hospital Universitari Santa Maria (Lleida, Spain)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Int J Nurs Stud. 2018 Jul;83:103. doi: 10.1016/j.ijnurstu.2018.04.014.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: aged; robotics; dehydration; nursing homes; fluid intake
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Infections; Water-Electrolyte Imbalance; Dehydration; Urinary Tract Infections
• Other Study ID Numbers: N23059; 2023 CLIMA 00047 (Other Grant/Funding Number: Agency for Management of University and Research Grants)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No