Clinical trial NCT05008640: Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
Official title: TrueLoo™: Determining the Feasibility of an Electronic Bowel Movement and Urinary Event Log Via In Situ Categorization of Physical Properties of Stool and Urine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Infectious Diarrhea
Clostridium Difficile Infection
Gastrointestinal Disease
GastroIntestinal Bleeding
Keywords: Geriatric
Gastroenterology
Urinary
Lead sponsor: Toi Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-17
Enrollment: 143
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was comprised of subjects that belong 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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™.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Bowel movement and urinary event dataset creation
timeFrame: Week 16 - 30
Secondary outcomes:
measure: Comparison with current methodologies
timeFrame: Week 16 - 30
Other outcomes:
measure: Identification of anomalous toileting patterns in TrueLoo™ data
timeFrame: Week 16 - 30
Locations:
city: Concord
country: United States
facility: Carlton Senior Living (Concord)
state: California
city: Davis
country: United States
facility: Carlton Senior Living (Davis)
state: California
city: Elk Grove
country: United States
facility: Carlton Senior Living (Elk Grove)
state: California
city: Sacramento
country: United States
facility: Eskaton Village Carmichael
state: California
city: Sacramento
country: United States
facility: Eskaton Lodge Cameron Park
state: California
city: Union City
country: United States
facility: Masonic Homes
state: California
Study officials:
affiliation: Toi Labs, Inc.
name: Paul F Cristman, PhD, MS, BS
role: PRINCIPAL_INVESTIGATOR
References: