Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT06520033
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotics as a Useful Tool to Improve the Hydration of the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Education level', 'timeFrame': 'Baseline', 'description': 'Choose between: no studies, primary studies, secondary studies and university studies.'}, {'measure': 'Birthdate', 'timeFrame': 'Baseline', 'description': 'Date of birth in yyyy/mm/dd format'}, {'measure': 'Marital status', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Date of institutionalization', 'timeFrame': 'Baseline', 'description': 'Date in yyyy/mm/dd format when the resident began to be institutionalized in the center.'}, {'measure': 'Sex', 'timeFrame': 'Baseline', 'description': 'Female or male sex'}], 'primaryOutcomes': [{'measure': 'Daily fluid intake', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'Amount in milliliters (ml)'}, {'measure': 'Urine color', 'timeFrame': '8 weeks', 'description': 'Urine color chart (Armstrong, 2000). Values = 1 - 8. Dehydration: scores \\>= 4'}, {'measure': 'Serum osmolarity', 'timeFrame': '8 weeks', 'description': 'Serum osmolarity: \\[1,86\\*(Na+K)+1,15\\*Glucose+urea+14)\\]. Dehydration \\> 300mOsm/kg'}, {'measure': 'Blood Urea Nitrogen', 'timeFrame': '8 weeks', 'description': 'BUN = Urea/2.1428. Dehydration \\> 20mg/dl'}, {'measure': 'Number of urinary infections', 'timeFrame': '8 weeks', 'description': 'Obtained through a urine sample and evaluated with the Combur-Test.'}], 'secondaryOutcomes': [{'measure': 'Dry Skin', 'timeFrame': '8 weeks', 'description': 'Skin turgor: if skin remains elevated after being pulled up and released'}, {'measure': 'Cognitive status', 'timeFrame': '8 weeks', 'description': 'The Mini Cognitive Examination (MEC) (Values = 0 - 30). Cognitive impairment: scores \\<= 23'}, {'measure': 'Cognitive status', 'timeFrame': '8 weeks', 'description': 'Global Deterioration Scale (GDS). Values = 1 - 7. Dementia: scores \\>= 3'}, {'measure': 'Risk of falls', 'timeFrame': '8 weeks', 'description': 'Downton scale. Values = 0 - 11. Risk of falls: scores \\> 2'}, {'measure': 'Illnesses', 'timeFrame': '8 weeks', 'description': 'Diseases that the participant currently presents'}, {'measure': 'Pharmacological treatment', 'timeFrame': '8 weeks', 'description': 'Number of medicines taken by the participant per day and type of medicine.'}, {'measure': 'Efficacy and safety of swallowing', 'timeFrame': '8 weeks', 'description': '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'}, {'measure': 'Nutritional status', 'timeFrame': '8 weeks', 'description': 'Assessed through the Mini Nutritional Assessment (MNA). Values = 0 - 30. Malnutrition: scores \\< 17'}, {'measure': 'Risk of pressure ulcers', 'timeFrame': '8 weeks', 'description': 'Braden Scale. Values = 6 - 23. Risk of pressure ulcers: scores \\< 19'}, {'measure': 'Functional status', 'timeFrame': '8 weeks', 'description': 'Barthel index. Values = 0 - 100. Functional impairment: scores \\< 90'}, {'measure': 'Hospital admissions', 'timeFrame': '8 weeks', 'description': 'Number of hospital admissions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dehydration', 'aged', 'nursing homes', 'robotics', 'fluid intake'], 'conditions': ['Dehydration', 'Daily Fluid Intake', 'Urinary Infections']}, 'referencesModule': {'references': [{'pmid': '33593070', 'type': 'BACKGROUND', 'citation': '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': '33158071', 'type': 'BACKGROUND', 'citation': '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': '30337227', 'type': 'BACKGROUND', 'citation': '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': '30525860', 'type': 'BACKGROUND', 'citation': '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': '29626702', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants:\n\n* The intervention group will receive a hydration plan executed by the robot and the control group will receive the center\\'s usual hydration plan.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 65 years.\n\nNo exclusion criteria have been established.'}, 'identificationModule': {'nctId': 'NCT06520033', 'acronym': 'Hidroponent', 'briefTitle': 'Robotics as a Useful Tool to Improve the Hydration of the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Lleida'}, 'officialTitle': 'Robotics as a Useful Tool to Improve the Hydration of the Elderly', 'orgStudyIdInfo': {'id': 'N23059'}, 'secondaryIdInfos': [{'id': '2023 CLIMA 00047', 'type': 'OTHER_GRANT', 'domain': 'Agency for Management of University and Research Grants'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group will receive a hydration plan executed by a humanoid robot.\n\nHealthcare personnel will receive reminders from the robot to record fluid intake through it.', 'interventionNames': ['Device: humanoid robot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group with', 'description': "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.", 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'humanoid robot', 'type': 'DEVICE', 'description': '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.\n\nThis intervention will last two months.', 'armGroupLabels': ['Intervention group']}, {'name': 'Usual care', 'type': 'OTHER', 'description': "The center's usual hydration plan", 'armGroupLabels': ['Control group with']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25005', 'city': 'Lleida', 'state': 'Lleida', 'country': 'Spain', 'facility': 'Residència i Centre de Dia per a Gent Gran Balàfia II', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Lleida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Management of University and Research Grants (Catalonia, Spain)', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitari Santa Maria (Lleida, Spain)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teresa Botigué Satorra', 'investigatorAffiliation': 'Universitat de Lleida'}}}}