AzTrials
AzTrials

DehydrationHidroponentNCT06520033

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

A study testing humanoid robot in people with Dehydration and Daily Fluid Intake, run by Universitat de Lleida at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
humanoid robot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteSpain
Study dates
8 May 2024to 6 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age equal to or greater than 65 years.
  • No exclusion criteria have been established.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Residència i Centre de Dia per a Gent Gran Balàfia II

    Lleida, Lleida, 25005

Other trials in Spain

About this study

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.
Being tested
humanoid robot, Usual care
Keywords
dehydration, aged, nursing homes, robotics, fluid intake
Medical subject headings
Dehydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • humanoid robotDevice

    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 careOther

    The center's usual hydration plan

Study groups in NCT06520033
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Device: humanoid robot
Control group withActive comparatorThe 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.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily fluid intake

    Amount in milliliters (ml)

    Measured: From enrollment to the end of intervention at 8 weeks

  2. Urine color

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

    Measured: 8 weeks

  3. Serum osmolarity

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

    Measured: 8 weeks

  4. Blood Urea Nitrogen

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

    Measured: 8 weeks

  5. Number of urinary infections

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

    Measured: 8 weeks

Secondary outcomes (11)

  1. Dry Skin

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

    Measured: 8 weeks

  2. Cognitive status

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

    Measured: 8 weeks

  3. Cognitive status

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

    Measured: 8 weeks

  4. Risk of falls

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

    Measured: 8 weeks

  5. Illnesses

    Diseases that the participant currently presents

    Measured: 8 weeks

  6. Pharmacological treatment

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

    Measured: 8 weeks

  7. 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

    Measured: 8 weeks

  8. Nutritional status

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

    Measured: 8 weeks

  9. Risk of pressure ulcers

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

    Measured: 8 weeks

  10. Functional status

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

    Measured: 8 weeks

  11. Hospital admissions

    Number of hospital admissions

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start8 May 2024
  3. Primary completion6 Sep 2024
  4. Study completion6 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06520033
Sponsor's protocol ID
N23059
Other IDs
2023 CLIMA 00047
Acronym
Hidroponent
Status last verified
Apr 2025
First submitted
26 Jun 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33593070

  • 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.

    PubMed 33158071

  • 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.

    PubMed 30337227

  • 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.

    PubMed 30525860

  • 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.

    PubMed 29626702

Questions about this trial

What is this clinical trial studying?

A study testing humanoid robot in people with Dehydration and Daily Fluid Intake, run by Universitat de Lleida at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily fluid intake (time frame: From enrollment to the end of intervention at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06520033, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in