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Completed

NCT Number: NCT06520033

Robotics as a Useful Tool to Improve the Hydration of the Elderly

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.

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Key information

Conditions

Dehydration Daily Fluid Intake Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Infections Water-Electrolyte Imbalance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Residència i Centre de Dia per a Gent Gran Balàfia II

Lleida, 25005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age equal to or greater than 65 years.

No exclusion criteria have been established.

Treatment and study plan

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.

Usual Care

Other

The center's usual hydration plan

Primary outcomes

  1. Daily fluid intake

    Time frame: From enrollment to the end of intervention at 8 weeks

    Amount in milliliters (ml)

  2. Urine color

    Time frame: 8 weeks

    Urine color chart (Armstrong, 2000). Values = 1 - 8. Dehydration: scores >= 4

  3. Serum osmolarity

    Time frame: 8 weeks

    Serum osmolarity: [1,86*(Na+K)+1,15*Glucose+urea+14)]. Dehydration > 300mOsm/kg

  4. Blood Urea Nitrogen

    Time frame: 8 weeks

    BUN = Urea/2.1428. Dehydration > 20mg/dl

  5. Number of urinary infections

    Time frame: 8 weeks

    Obtained through a urine sample and evaluated with the Combur-Test.

Secondary outcomes

  1. Dry Skin

    Time frame: 8 weeks

    Skin turgor: if skin remains elevated after being pulled up and released

  2. Cognitive status

    Time frame: 8 weeks

    The Mini Cognitive Examination (MEC) (Values = 0 - 30). Cognitive impairment: scores <= 23

  3. Cognitive status

    Time frame: 8 weeks

    Global Deterioration Scale (GDS). Values = 1 - 7. Dementia: scores >= 3

  4. Risk of falls

    Time frame: 8 weeks

    Downton scale. Values = 0 - 11. Risk of falls: scores > 2

  5. Illnesses

    Time frame: 8 weeks

    Diseases that the participant currently presents

  6. Pharmacological treatment

    Time frame: 8 weeks

    Number of medicines taken by the participant per day and type of medicine.

  7. Efficacy and safety of swallowing

    Time frame: 8 weeks

    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. Nutritional status

    Time frame: 8 weeks

    Assessed through the Mini Nutritional Assessment (MNA). Values = 0 - 30. Malnutrition: scores < 17

  9. Risk of pressure ulcers

    Time frame: 8 weeks

    Braden Scale. Values = 6 - 23. Risk of pressure ulcers: scores < 19

  10. Functional status

    Time frame: 8 weeks

    Barthel index. Values = 0 - 100. Functional impairment: scores < 90

  11. Hospital admissions

    Time frame: 8 weeks

    Number of hospital admissions

Other outcomes

  1. Education level

    Time frame: Baseline

    Choose between: no studies, primary studies, secondary studies and university studies.

  2. Birthdate

    Time frame: Baseline

    Date of birth in yyyy/mm/dd format

  3. Marital status

    Time frame: Baseline

    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).

  4. Date of institutionalization

    Time frame: Baseline

    Date in yyyy/mm/dd format when the resident began to be institutionalized in the center.

  5. Sex

    Time frame: Baseline

    Female or male sex

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Collaborators

  • Agency for Management of University and Research Grants (Catalonia, Spain)
  • Hospital Universitari Santa Maria, Spain

Registry information

Acronym: Hidroponent

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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