Clinical trial NCT03209570: A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
Official title: A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence, nursing home
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Essity Hygiene and Health AB
First posted: 2017-07-06
Enrollment: 49
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wet Events Per 24 Hours
timeFrame: 6 days
Secondary outcomes:
measure: Time Wet Per 24 Hours
timeFrame: 6 days
measure: Number of Brief Changes Per 24 Hours
timeFrame: 6 days
Other outcomes:
Locations:
city: Chesapeake
country: United States
facility: Chesapeake Health & Rehabilitation Center
state: Virginia
city: Norfolk
country: United States
facility: Norfolk Health & Rehabilitation Center
state: Virginia
city: Norfolk
country: United States
facility: Insight Therapeutics, LLC
state: Virginia
city: Virginia Beach
country: United States
facility: Westminster-Canterbury on Chesapeake Bay
state: Virginia
city: Virginia Beach
country: United States
facility: Beth Sholom Village
state: Virginia
Study officials:
affiliation: Brown University
name: Stefan Gravenstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Insight Therapeutics, LLC
name: H Edward Davidson, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.