A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Care planning using TENA Identifi sensor wear data
* Other: Care planning without using TENA Identifi sensor wear data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 55 years of age or older with stable clinical status Long-stay status (more than 90 days) Ambulatory and able to use a toilet either independently or with assistance Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence Currently wearing disposable briefs for urinary incontinence Exclusion Criteria: Chronically bed-bound (MDS G0110A rating 8) MDS self-performance rating of 4 (total dependence) for toilet use Fecal incontinence (MDS H0400 rating 0) Use of urinary appliance such as catheters or ostomies (MDS H0100 Z) Private duty nurse care Residents who tear at clothing or disposable undergarments Current urinary tract infection receiving treatment Current diarrhea receiving treatment Residents who are not likely to benefit from a toileting plan based on assessment of nursing staff

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENA Identifi with sensor wear data<br>All individuals in this arm will receive care planning using TENA Identifi sensor wear data | Other: Care planning using TENA Identifi sensor wear data<br>* All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning.<br>|
| Active Comparator: TENA Identifi without sensor wear data<br>All individuals in this arm will receive care planning without using TENA Identifi sensor wear data | Other: Care planning without using TENA Identifi sensor wear data<br>* All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, nursing home