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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209570
• Other study ID #: INSI-201706
• Status: Completed
• Phase: N/A
• Start date: October 19, 2017
• Est. completion date: August 11, 2018

Study information

• Verified date: July 2019
• Source: Insight Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 11, 2018
• Est. primary completion date: August 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Males or females 55 years of age or older with stable clinical status

2. Long-stay status (more than 90 days)

3. Ambulatory and able to use a toilet either independently or with assistance

4. Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence

5. Currently wearing disposable briefs for urinary incontinence

Exclusion Criteria:

1. Chronically bed-bound (MDS G0110A rating 8)

2. MDS self-performance rating of 4 (total dependence) for toilet use

3. Fecal incontinence (MDS H0400 rating 0)

4. Use of urinary appliance such as catheters or ostomies (MDS H0100 Z)

5. Private duty nurse care

6. Residents who tear at clothing or disposable undergarments

7. Current urinary tract infection receiving treatment

8. Current diarrhea receiving treatment

9. Residents who are not likely to benefit from a toileting plan based on assessment of nursing staff

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Chesapeake Health & Rehabilitation Center	Chesapeake	Virginia
United States	Insight Therapeutics, LLC	Norfolk	Virginia
United States	Norfolk Health & Rehabilitation Center	Norfolk	Virginia
United States	Beth Sholom Village	Virginia Beach	Virginia
United States	Westminster-Canterbury on Chesapeake Bay	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Insight Therapeutics, LLC	Essity

Country where clinical trial is conducted

United States, 

References & Publications (2)

Omli R, Skotnes LH, Romild U, Bakke A, Mykletun A, Kuhry E. Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents. Age Ageing. 2010 Sep;39(5):549-54. doi: 10.1093/ageing/afq082. Epub 2010 Jul 14. — View Citation

Ouslander JG, Schnelle JF, Uman G, Fingold S, Nigam JG, Tuico E, Bates-Jensen B. Predictors of successful prompted voiding among incontinent nursing home residents. JAMA. 1995 May 3;273(17):1366-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Brief Changes Per 24 Hours	The number of brief changes per 24 hours, intervention versus control	6 days

External Links

•   urinary incontinence training module; includes description of standard of care incontinence assessment for nursing home residents