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Completed

NCT Number: NCT03209570

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chesapeake Health & Rehabilitation Center, Chesapeake, Virginia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Wet Events Per 24 Hours

    Time frame: 6 days

    Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control

Secondary outcomes

  1. Time Wet Per 24 Hours

    Time frame: 6 days

    Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control

  2. Number of Brief Changes Per 24 Hours

    Time frame: 6 days

    The number of brief changes per 24 hours, intervention versus control

Sponsors and collaborators

Lead sponsor

Insight Therapeutics, LLC

Other

Collaborators

  • Essity Hygiene and Health AB

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2017
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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