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| Name | Class |
|---|---|
| Essity Hygiene and Health AB | INDUSTRY |
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The purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.
Urinary incontinence in nursing homes influences resident dignity and quality of life. It also drives significant use of healthcare resources, including time and caregiver assistance, and costs of care. Various toileting programs are used to address urinary incontinence, including habit training, bladder training, prompted voiding, and check and change procedures. Clinical trials have found that 33% to 60% of residents either became continent or reduced the frequency of incontinence episodes to less than one per day with the introduction of a prompted voiding program.
There are several drawbacks to current programs. Manually recorded wet checks do not identify when incontinence occurs, only when wetness is detected, reducing the precision of time of incontinence to the window of time between checks. Nursing home staff create individualized care plans for each resident, based on standard check and change procedures, but poor precision in ascertaining timing and quantity of incontinence episodes can contribute to less frequent resident toileting or changing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENA Identifi with sensor wear data | Experimental | All individuals in this arm will receive care planning using TENA Identifi sensor wear data |
|
| TENA Identifi without sensor wear data | Active Comparator | All individuals in this arm will receive care planning without using TENA Identifi sensor wear data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care planning using TENA Identifi sensor wear data | Other | All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wet Events Per 24 Hours | Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time Wet Per 24 Hours | Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control | 6 days |
| Number of Brief Changes Per 24 Hours | The number of brief changes per 24 hours, intervention versus control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Gravenstein, MD, MPH | Brown University | Principal Investigator |
| H Edward Davidson, PharmD, MPH | Insight Therapeutics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Health & Rehabilitation Center | Chesapeake | Virginia | 23320 | United States | ||
| Norfolk Health & Rehabilitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7715062 | Background | Ouslander JG, Schnelle JF, Uman G, Fingold S, Nigam JG, Tuico E, Bates-Jensen B. Predictors of successful prompted voiding among incontinent nursing home residents. JAMA. 1995 May 3;273(17):1366-70. | |
| 20631404 | Background | Omli R, Skotnes LH, Romild U, Bakke A, Mykletun A, Kuhry E. Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents. Age Ageing. 2010 Sep;39(5):549-54. doi: 10.1093/ageing/afq082. Epub 2010 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TENA Identifi With Sensor Wear Data | All individuals in this arm will receive care planning using TENA Identifi sensor wear data Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning. |
| FG001 | TENA Identifi Without Sensor Wear Data | All individuals in this arm will receive care planning without using TENA Identifi sensor wear data Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TENA Identifi With Sensor Wear Data | All individuals in this arm will receive care planning using TENA Identifi sensor wear data Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wet Events Per 24 Hours | Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control | The study design is a two group, two time-point, four site, randomized, longitudinal clinical trial. Means were generated by averaging the 3 daily counts in each assessment period (pre-intervention and post-intervention) for each group (control versus intervention). | Posted | Least Squares Mean | Standard Error | events per 24 hours | 6 days |
|
Adverse events were collected for 6 days/ two 72hr time periods (randomization through study completion)
no additional adverse events were reported by nursing facilities
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TENA Identifi With Sensor Wear Data | All individuals in this arm will receive care planning using TENA Identifi sensor wear data Care planning using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Resident was consented and randomized but passed away before sensor wear was placed on resident. No assessments occurred. |
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small sample size, lack of time and resources for facilities to assist with study, and resident's removing sensor wear.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Edward Davidson, PharmD, MPH | Insight Therapeutics, LLC | 7576246040 | EDavidson@inther.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2018 | Jan 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Care planning without using TENA Identifi sensor wear data | Other | All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning. |
|
| 6 days |
| Norfolk |
| Virginia |
| 23504 |
| United States |
| Insight Therapeutics, LLC | Norfolk | Virginia | 23510 | United States |
| Westminster-Canterbury on Chesapeake Bay | Virginia Beach | Virginia | 23451 | United States |
| Beth Sholom Village | Virginia Beach | Virginia | 23464 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| TENA Identifi Without Sensor Wear Data |
All individuals in this arm will receive care planning without using TENA Identifi sensor wear data Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| TENA Identifi Without Sensor Wear Data |
All individuals in this arm will receive care planning without using TENA Identifi sensor wear data Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning. |
|
|
| Secondary | Time Wet Per 24 Hours | Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control | Posted | Least Squares Mean | Standard Error | hours per 24 hours | 6 days |
|
|
|
| Secondary | Number of Brief Changes Per 24 Hours | The number of brief changes per 24 hours, intervention versus control | Posted | Least Squares Mean | Standard Error | events per 24 hours | 6 days |
|
|
|
| 1 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | TENA Identifi Without Sensor Wear Data | All individuals in this arm will receive care planning without using TENA Identifi sensor wear data Care planning without using TENA Identifi sensor wear data: All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning. | 0 | 12 | 0 | 12 | 0 | 12 |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |