Effectiveness of a Wearable Hydration Device
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorMetroHealth Medical Center
About this trial
Dehydration among older adults a costs billions of dollars in US healthcare every year because no robust solution exists to detect changes in hydration and prevent negative outcomes. In this project, TritonX Technologies Inc. and academic research partners plan to test whether a newly created wearable sensor that measures hydration in real time can promote hydration and prevent the dehydration illnesses.
The investigators will conduct a randomized controlled trial to examine the effectiveness of continuous home monitoring of fluid levels in a cohort of vulnerable older adult patients seen in the emergency care setting.
The goal of this randomized control trial is to examine the effectiveness of continuous home monitoring of fluid levels in older patients presenting to the emergency department for dehydration. The main questions it aims to answer:
1. Can a wearable device accurately determine the severity of dehydration at home and 2. can a wearable device and continuous feedback from the device change behavior in the outpatient setting that can lead to improved outcomes in the treatment of dehydration in the elderly?
Investigators will compare device readings, hydration diaries, vital signs, blood samples, return visits to the emergency department, and to see if feedback from the device decreases signs and symptoms of dehydration and changes home management of dehydration.
Participants will be asked to:
* wear the device and monitor hydration status * record the amount of home hydration * return in 7-10 days for reassessment of dehydration
The successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA 510(k) and related regulatory processes and substantial enhancements to both our knowledge of older adult needs and device functionality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients aged 55 and over
rresenting to the emergency department
clinical suspicion of dehydration
treatment of dehydration/syncope with fluid resuscitation
Disqualifiers
Refusal or inability to give informed consent,
severe clinical symptom requiring escalation of care beyond fluid resuscitation (ex. vasopressors, invasive blood pressure monitoring)
presumed/confirmed diagnosis of syncope secondary to a non-dehydration cause (ex. arrhythmia, stroke, pulmonary embolism, sepsis, valvular heart disease)
inability to lay flat for the test
Trial design
Design model
Parallel
Treatments tested in this trial
Device with Phone App
DeviceThis is the intervention where the patients will be given both the wearable dehydration device as well as the phone app
Device without Phone App
DeviceThis is the intervention where the patients will receive the device alone
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Device with Interactive Phone AppActive comparator 1 intervention
Group B: Device without Interactive Phone APpSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average daily fluid intake in mL
The average daily fluid intake over 10 days as determined by a standardized Drink Diary
Time frame
10 daysSecondary outcomes
1
Level of total body water after 10 days
Total body water after 10 days will be determined by the wearable dehydration device
Time frame
10 days2
Midpoint Clinical symptoms of dehydration
Midpoint telehealth visit reports of syncope, dizziness, feeling of confusion, increased thirst, reported decreased urinary output, feeling fatigued
Time frame
5 days3
End of Study Report of Dehydration
Any reported syncope, dizziness, feeling of confusion, increased thirst, reported decreased urinary output, feeling fatigued.
Time frame
10 days4
End of Study Visit Heart Rate (beats per minute)
HR \>100 would be considered abnormal
Time frame
10 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MetroHealth Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: