A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
Phase: NA
Conditions: Urinary Incontinence
Sponsor: Insight Therapeutics, LLC

 
A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting 
 
 
 
 
Principal Investigator: 
 
H. Edward Davidson, PharmD, MPH 
Insight Therapeutics, LLC 
 
 
 
Sub-Investigators: 
Stefan Gravenstein, MD, MPH 
Providence VA Medical Center  
Ocean State Research Institute, Inc 
Lisa F. Han, MPH 
RK Elswick, PhD 
Melissa LaMantia, MA 
Insight Therapeutics, LLC 
 
 
 
 
 
 
 
 
 
 
 
 
 
Insight Therapeutics, LLC 
142 W. York Street, Suite 605 
Norfolk, VA 23510 
757-625-6040 
757-625-4538 (fax) 
 
Original: May 22, 2017 
Amended: September 8, 2017 
Amended: December 18, 2017 
Amended: May 3, 2018 
Amended: June 12, 2018 
 

 
June 12, 2018  
CONFIDENTIAL     © Insight Therapeutics, LLC 2017 
Objective 
 
The purpose of this pilot 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, secondarily, whether such data differentially improve 
a care planning strategy, nursing effort, product use, and wet-time for UI. 
 
Primary Outcome: 
1. Comparison of number of wet events per 24 hours, as recorded by TENA Identifi, intervention 
versus control 
 
Secondary Outcomes: 
1. Comparison of amount of time wet per 24 hours, intervention versus control 
2. Comparison of number of disposable briefs per 24 hours, intervention versus control 
3. Nursing staff (e.g., assistants, care planners) satisfaction with using TENA Identifi  
4. Nursing staff assessment of ease of use of TENA Identifi for recording and care planning 
compared to their current check and change care standard(s) 
5. Value of TENA Identifi system to nursing staff in developing care plans 
 
Study Design 
This quasi-experimental study compares treatment plans of NH residents in two different groups—those 
informed by data from the TENA Identifi system to those informed by standards of care already in 
practice within nursing homes. The TENA Identifi system consists of a sensor integrated with a 
disposable brief that provides a digital time stamp of each wet event when a resident is changed, how 
long a resident has been exposed to urinary moisture without being changed (i.e., damp segments), and 
volume of urinary output from each wet event. These data are captured in a TENA Identifi Report that 
the nursing home staff can use fore care planning. 
The study staff will consent 32 long-stay residents (or their legally authorized representative) for 
inclusion in our study from different nursing homes that meet our inclusion criteria. The study will be 
approved by all relevant Institutional Review Boards prior to beginning study activities.  
Eligibility Criteria 
Inclusion Criteria for Residents: 
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), Level 2 (frequently) or 3 (always) rating of 
incontinence  
5. Currently wearing disposable briefs for urinary incontinence 
 
 
 
 
 
 

 
June 12, 2018  
CONFIDENTIAL     © Insight Therapeutics, LLC 2017 
Exclusion Criteria for Residents: 
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 
Inclusion Criteria for Nursing Homes: 
1. Medicare or Medicaid certified nursing facilities in the U.S. 
2. Use of a nursing aide care tracking device (e.g., CareTrackerTM, HealthMEDX), electronic health 
record, and/or paper voiding diaries  
3. Provides care for residents 55 years of age and older 
Exclusion Criteria for Nursing Homes: 
1. Nursing homes that do not report MDS data to CMS 
2. Unwilling to participate in TENA Identifi training and use 
Each NH will have a control and intervention group. Control and intervention groups will be randomized 
and consist of 16 residents each.  Nursing staff will receive TENA Identifi training on how to use the 
device prior to beginning  Observation 1 assessment. Both groups will receive an assessment of the NH’s 
current standard of care procedure for UI assessment and care planning between observational periods. 
Both groups will wear disposable briefs with the TENA Identifi sensor for 72 consecutive hours. Nursing 
staff in both groups will follow standard of care check and change procedures during this time period. 
After the 72-hour period with parallel check and change assessment, data collected by the TENA Identifi 
sensor will be assessed in the intervention group and used to create new treatment plans. 
Nursing staff for the control group will be blinded to sensor data and will create new treatment plans 
based on usual care planning processes. Modified treatment plans will be implemented in both groups 
and observed for a final 72 consecutive hours using TENA Identifi in both groups. TENA Identifi sensor 
data will be collected from both groups during this period (sensor data from the control group will be 
used as control data), and the data will be compared. Nursing staff will be surveyed to obtain data on 
ease of use with TENA Identifi and interpreting its data, as well as how it compares to other standard of 
care recording methods. 

 
June 12, 2018  
CONFIDENTIAL     © Insight Therapeutics, LLC 2017 
Statistical Analysis Plan 
 
The study design is a two group, two timepoint, four site, randomized, longitudinal clinical trial. 
Descriptive statistics were computed for demographic data from the MDS, medications from the 
medication administration record, and TENA Identifi sensor data (i.e., number of wet events per 24 
hours, the amount of time the resident was wet per 24 hours, and the number of brief changes). The 
means for number of wet events and number of brief changes were generated by averaging the 3 daily 
counts in each assessment period. The first assessment period was pre-intervention and the second 
assessment was post-intervention. A mixed-effects linear model was used to compare the intervention 
vs. control. Fixed effects included group (intervention vs. control), time and the group by time 
interaction. Random effects included site and participant. A random effect for the site by group 
interaction was planned but not estimable due the fact that only the intervention group was tested at 
the first site. For this model, the group by time interaction was a test of the intervention. Least square 
(or adjusted means) along with their standard errors were reported from the mixed-effects model. 
Significance was set at a p-value of 0.05.  
These data will be collected using four data sources and recorded on a study-specific case report form: 
A. TENA Identifi sensor data. This electronic monitoring system provides real-time data of 
residents’ voiding patterns including time at which a wet event occurred (i.e., minimum of 2 
sensor segments on TENA Identifi Report), how long a resident was wet after voiding (i.e., 
damp segments), and urinary output (i.e., void volume). These data are collected over a 
consecutive three-day period through a sensor worn in a disposable brief and automatically 
transmitted to a secure online web portal where it is converted into a detailed voiding 
report. It is anticipated that data collection will begin on a Tuesday at 8 AM and be 
completed at 8AM on Friday for a total collection period of 72 hours. The TENA Identifi 
logger and sensor briefs are not provided to facilities after completion of the study. 
 
B. CareTrackerTM, HealthMEDX, other electronic or paper tracking data, which contains 
manually recorded voiding information including when residents are checked and changed 
and number and time of wet events. 
 
C. Minimum Data Set (MDS), which contains health information on each resident, including 
residents’ functional status and capabilities, as well as any health problems. 
 
D. Medication administration record, which contains information on medications administered 
to NH residents. 
Data for some secondary outcomes will be collected using a survey given post-study to nursing staff.