NCT03209570

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Insight Therapeutics, LLC · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2017-10-19
• Primary completion: 2018-08-11
• Completion: 2018-08-11
• First posted: 2017-07-06
• Last updated: 2019-07-26
• Results posted: 2019-07-26

Locations

5 sites across 1 country: United States