A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
1 other identifier
interventional
49
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2018
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedJuly 26, 2019
July 1, 2019
10 months
July 3, 2017
February 13, 2019
July 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Time Wet Per 24 Hours
6 days
Number of Brief Changes Per 24 Hours
6 days
Study Arms (2)
TENA Identifi with sensor wear data
EXPERIMENTALAll individuals in this arm will receive care planning using TENA Identifi sensor wear data
TENA Identifi without sensor wear data
ACTIVE COMPARATORAll individuals in this arm will receive care planning without using TENA Identifi sensor wear data
Interventions
All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning.
All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insight Therapeutics, LLClead
- Essity Hygiene and Health ABcollaborator
Study Sites (5)
Chesapeake Health & Rehabilitation Center
Chesapeake, Virginia, 23320, United States
Norfolk Health & Rehabilitation Center
Norfolk, Virginia, 23504, United States
Insight Therapeutics, LLC
Norfolk, Virginia, 23510, United States
Westminster-Canterbury on Chesapeake Bay
Virginia Beach, Virginia, 23451, United States
Beth Sholom Village
Virginia Beach, Virginia, 23464, United States
Related Publications (2)
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.
PMID: 7715062BACKGROUNDOmli 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.
PMID: 20631404BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
small sample size, lack of time and resources for facilities to assist with study, and resident's removing sensor wear.
Results Point of Contact
- Title
- H. Edward Davidson, PharmD, MPH
- Organization
- Insight Therapeutics, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Gravenstein, MD, MPH
Brown University
- PRINCIPAL INVESTIGATOR
H Edward Davidson, PharmD, MPH
Insight Therapeutics, LLC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2017
First Posted
July 6, 2017
Study Start
October 19, 2017
Primary Completion
August 11, 2018
Study Completion
August 11, 2018
Last Updated
July 26, 2019
Results First Posted
July 26, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share