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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Care planning using TENA Identifi sensor wear data; Other: Care planning without using TENA Identifi sensor wear data

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Chesapeake Health & Rehabilitation Center
    • Norfolk, Virginia, United States, 23510
      • Insight Therapeutics, LLC
    • Norfolk, Virginia, United States, 23504
      • Norfolk Health & Rehabilitation Center
    • Virginia Beach, Virginia, United States, 23451
      • Westminster-Canterbury on Chesapeake Bay
    • Virginia Beach, Virginia, United States, 23464
      • Beth Sholom Village

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENA Identifi with sensor wear data; All individuals in this arm will receive care planning using TENA Identifi sensor wear data	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.
Active Comparator: TENA Identifi without sensor wear data; All individuals in this arm will receive care planning without using TENA Identifi sensor wear data	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Brief Changes Per 24 Hours	The number of brief changes per 24 hours, intervention versus control	6 days

Collaborators and Investigators

• Sponsor: Insight Therapeutics, LLC
• Collaborators: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Stefan Gravenstein, MD, MPH, Brown University; Principal Investigator: H Edward Davidson, PharmD, MPH, Insight Therapeutics, LLC

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): August 11, 2018
• Study Completion (Actual): August 11, 2018

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: urinary incontinence, nursing home
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents; Zinc Oxide
• Other Study ID Numbers: INSI-201706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No