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

Not Applicable

Completed

Interventions: Other: Care planning without using TENA Identifi sensor wear data
Other: Care planning using TENA Identifi sensor wear data

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TENA Identifi without sensor wear data	Care planning without using TENA Identifi sensor wear data	All individuals in this arm will receive care planning without using TENA Identifi sensor wear data
TENA Identifi with sensor wear data	Care planning using TENA Identifi sensor wear data	All individuals in this arm will receive care planning using TENA Identifi sensor wear data

Primary Outcome Measures

Name	Time	Method
Wet Events Per 24 Hours	6 days	Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control

Secondary Outcome Measures

Name	Time	Method
Time Wet Per 24 Hours	6 days	Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control
Number of Brief Changes Per 24 Hours	6 days	The number of brief changes per 24 hours, intervention versus control

Locations (5): Chesapeake Health & Rehabilitation Center
🇺🇸
Chesapeake, Virginia, United States
Norfolk Health & Rehabilitation Center
🇺🇸
Norfolk, Virginia, United States
Insight Therapeutics, LLC
🇺🇸
Norfolk, Virginia, United States
Westminster-Canterbury on Chesapeake Bay
🇺🇸
Virginia Beach, Virginia, United States
Beth Sholom Village
🇺🇸
Virginia Beach, Virginia, United States