Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
- Conditions
- Clostridium Difficile InfectionGastroIntestinal BleedingInfectious DiarrheaUrinary Tract InfectionsGastrointestinal Disease
- Interventions
- Device: TrueLoo™
- Registration Number
- NCT05008640
- Lead Sponsor
- Toi Labs, Inc.
- Brief Summary
The purpose of this study is to assess the feasibility of TrueLoo™, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across Northern California.
- Detailed Description
The logging and monitoring of bowel movements and urinary events is an important aspect of preventative care for residents in senior living facilities, providing early warning signs for conditions that may otherwise cause complications if dealt with reactively. However, this information is sporadically collected - if at all - and subjectively interpreted by caregivers, leading to inconsistencies and unreliable data. Toi Labs, Inc. has created TrueLoo™, an Internet-connected toilet seat, as a solution to these issues. TrueLoo™ acquires time-lapse images of a bowel movement or urinary event automatically and under controlled conditions. Residents enrolled in the current study will have a TrueLoo™ installed in their private bathroom, through which all bowel movements and urinary events will be tracked, anonymously, privately, and securely. As a result, an electronic bowel movement and urinary event log for each enrolled resident will be generated. Given sufficient data, the TrueLoo™ system will complete such electronic logs automatically, identify points in time where particular enrolled residents may have experienced anomalous toileting patterns, and determine the relevance of such events through targeted health history and urine sampling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- Must be willing to participate and provide consent for the study;
- Must be a male or female, aged 55 or older;
- Must be a resident of a senior living facility;
- Must have regular access to a TrueLoo™.
- Candidates who are unwilling or unable to accept the requirements associated with installing TrueLoo™ in their residence, including power and Wi-Fi connectivity;
- Candidates who use certain types of toileting assistance devices that at this time are not compatible with TrueLoo™ (e.g., padded toilet seat risers).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group (all subjects) TrueLoo™ All subjects belonged to the same study group, regardless of symptoms, disease diagnosis or state. Furthermore, there was no stratification of the population by sex, age, race or disease severity.
- Primary Outcome Measures
Name Time Method Bowel movement and urinary event dataset creation Week 16 - 30 Number of urinations and bowel movements exhibited from each participant during the study period, as observed by TrueLoo™ image analysis.
- Secondary Outcome Measures
Name Time Method Comparison with current methodologies Week 16 - 30 Error rate of bowel movement and urinary event tracking from current caregiver-reported and self-reported methods.
Trial Locations
- Locations (6)
Carlton Senior Living (Elk Grove)
🇺🇸Elk Grove, California, United States
Carlton Senior Living (Davis)
🇺🇸Davis, California, United States
Carlton Senior Living (Concord)
🇺🇸Concord, California, United States
Eskaton Lodge Cameron Park
🇺🇸Sacramento, California, United States
Eskaton Village Carmichael
🇺🇸Sacramento, California, United States
Masonic Homes
🇺🇸Union City, California, United States