NCT06520033

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

June 26, 2024

Last Update Submit

April 8, 2025

Conditions

Keywords

dehydrationagednursing homesroboticsfluid intake

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • Dry Skin

    8 weeks

  • Cognitive status

    8 weeks

  • Cognitive status

    8 weeks

  • Risk of falls

    8 weeks

  • Illnesses

    8 weeks

  • +6 more secondary outcomes

Other Outcomes (5)

  • Education level

    Baseline

  • Birthdate

    Baseline

  • Marital status

    Baseline

  • +2 more other outcomes

Study Arms (2)

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.

Device: humanoid robot

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.

Other: Usual care

Interventions

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.

Intervention group

The center's usual hydration plan

Control group with

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age equal to or greater than 65 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Residència i Centre de Dia per a Gent Gran Balàfia II

Lleida, Lleida, 25005, Spain

Location

Related Publications (5)

  • 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.

    PMID: 33593070BACKGROUND
  • 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.

    PMID: 33158071BACKGROUND
  • 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.

    PMID: 30337227BACKGROUND
  • 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.

    PMID: 30525860BACKGROUND
  • 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.

    PMID: 29626702BACKGROUND

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 25, 2024

Study Start

May 8, 2024

Primary Completion

September 6, 2024

Study Completion

September 6, 2024

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations