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

Insight Therapeutics

Status: Completed

Conditions: Urinary Incontinence

Treatments: Other: Care planning without using TENA Identifi sensor wear data; Other: Care planning using TENA Identifi sensor wear data

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03209570

INSI-201706

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

TENA Identifi with sensor wear data

Experimental group

Description:

All individuals in this arm will receive care planning using TENA Identifi sensor wear data

Treatment:

Other: Care planning using TENA Identifi sensor wear data

TENA Identifi without sensor wear data

Active Comparator group

Description:

All individuals in this arm will receive care planning without using TENA Identifi sensor wear data

Treatment:

Other: Care planning without using TENA Identifi sensor wear data