- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05008640
Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
August 9, 2021 updated by: Toi Labs, Inc.
TrueLoo™: Determining the Feasibility of an Electronic Bowel Movement and Urinary Event Log Via In Situ Categorization of Physical Properties of Stool and Urine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Concord, California, United States, 94520
- Carlton Senior Living (Concord)
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Davis, California, United States, 95618
- Carlton Senior Living (Davis)
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Elk Grove, California, United States, 95758
- Carlton Senior Living (Elk Grove)
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Sacramento, California, United States, 95608
- Eskaton Village Carmichael
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Sacramento, California, United States, 95682
- Eskaton Lodge Cameron Park
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Union City, California, United States, 94587
- Masonic Homes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group (all subjects)
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.
|
TrueLoo™ is an Internet-connected, smart toilet seat that uses computer vision technology to log and capture daily bowel movements and urinations.
This data is then categorized by physical excreta characteristics to train and develop machine learning algorithms that are intended to eventually identify significant changes in stool and urine in real-time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bowel movement and urinary event dataset creation
Time Frame: Week 16 - 30
|
Number of urinations and bowel movements exhibited from each participant during the study period, as observed by TrueLoo™ image analysis.
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Week 16 - 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison with current methodologies
Time Frame: Week 16 - 30
|
Error rate of bowel movement and urinary event tracking from current caregiver-reported and self-reported methods.
|
Week 16 - 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of anomalous toileting patterns in TrueLoo™ data
Time Frame: Week 16 - 30
|
Number of bowel movement and urinary event anomalies observed by TrueLoo™; ad-hoc health history collection and urine sampling will determine the relevance of these events.
|
Week 16 - 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul F Cristman, PhD, MS, BS, Toi Labs, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2019
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
June 18, 2021
Study Registration Dates
First Submitted
July 14, 2021
First Submitted That Met QC Criteria
August 9, 2021
First Posted (Actual)
August 17, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Signs and Symptoms, Digestive
- Hemorrhage
- Gastroenteritis
- Intestinal Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Infections
- Communicable Diseases
- Diarrhea
- Urinary Tract Infections
- Gastrointestinal Diseases
- Digestive System Diseases
- Clostridium Infections
- Gastrointestinal Hemorrhage
- Dysentery
Other Study ID Numbers
- 20191822 (Other Identifier: WCG IRB (IRB #))
- TLSD-001 (Other Identifier: WCG IRB (Protocol #))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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