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

Completed · Not applicable

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03209570

Run by

Insight Therapeutics, LLC

People needed

49

Starts

2017-10-19

Expected to finish

2018-08-11

Last updated by the study team

2019-07-26

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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