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| ID | Type | Description | Link |
|---|---|---|---|
| 20191822 | Other Identifier | WCG IRB (IRB #) | |
| TLSD-001 | Other Identifier | WCG IRB (Protocol #) |
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The purpose of this study is to assess the feasibility of TrueLooâ„¢, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across Northern California.
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 TrueLooâ„¢, an Internet-connected toilet seat, as a solution to these issues. TrueLooâ„¢ 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 TrueLooâ„¢ 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 TrueLooâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueLooâ„¢ | Device | TrueLooâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movement and urinary event dataset creation | Number of urinations and bowel movements exhibited from each participant during the study period, as observed by TrueLooâ„¢ image analysis. | Week 16 - 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison with current methodologies | Error rate of bowel movement and urinary event tracking from current caregiver-reported and self-reported methods. | Week 16 - 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of anomalous toileting patterns in TrueLooâ„¢ data | Number of bowel movement and urinary event anomalies observed by TrueLooâ„¢; ad-hoc health history collection and urine sampling will determine the relevance of these events. | Week 16 - 30 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paul F Cristman, PhD, MS, BS | Toi Labs, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlton Senior Living (Concord) | Concord | California | 94520 | United States | ||
| Carlton Senior Living (Davis) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2019 | Jul 12, 2021 |
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|
| Davis |
| California |
| 95618 |
| United States |
| Carlton Senior Living (Elk Grove) | Elk Grove | California | 95758 | United States |
| Eskaton Village Carmichael | Sacramento | California | 95608 | United States |
| Eskaton Lodge Cameron Park | Sacramento | California | 95682 | United States |
| Masonic Homes | Union City | California | 94587 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004403 | Dysentery |
| D003015 | Clostridium Infections |
| D005767 | Gastrointestinal Diseases |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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