Urinary Incontinence
Conditions
Keywords
urinary incontinence, nursing home
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.
Interventions
OTHERCare 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.
OTHERCare 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.
Sponsors
Essity Hygiene and Health AB
Insight Therapeutics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wet Events Per 24 Hours | 6 days | Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Wet Per 24 Hours | 6 days | Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control |
| Number of Brief Changes Per 24 Hours | 6 days | The number of brief changes per 24 hours, intervention versus control |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TENA Identifi With Sensor Wear Data All individuals in this arm will receive care planning using TENA Identifi sensor wear data
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. | 14 |
| TENA Identifi Without Sensor Wear Data All individuals in this arm will receive care planning without using TENA Identifi sensor wear data
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. | 12 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Incomplete Data | 8 | 10 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | TENA Identifi With Sensor Wear Data | TENA Identifi Without Sensor Wear Data | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 84.7 years STANDARD_DEVIATION 14.5 | 79.4 years STANDARD_DEVIATION 11.8 | 82.3 years STANDARD_DEVIATION 13.4 |
| BMI | 28.2 kg/m^2 STANDARD_DEVIATION 7.23 | 25.9 kg/m^2 STANDARD_DEVIATION 6.6 | 27.1 kg/m^2 STANDARD_DEVIATION 6.9 |
| Height | 64.6 inches STANDARD_DEVIATION 5.2 | 63.8 inches STANDARD_DEVIATION 3.8 | 64.2 inches STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 8 Participants | 17 Participants |
| Region of Enrollment United States | 14 participants | 12 participants | 26 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 14 | 0 / 12 |
| serious Total, serious adverse events | 1 / 14 | 0 / 12 |
Outcome results
Primary
Wet Events Per 24 Hours
Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control
Time frame: 6 days
Population: The study design is a two group, two time-point, four site, randomized, longitudinal clinical trial. Means were generated by averaging the 3 daily counts in each assessment period (pre-intervention and post-intervention) for each group (control versus intervention).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| TENA Identifi With Sensor Wear Data | Wet Events Per 24 Hours | Days 1-3 | 8.11 events per 24 hours | Standard Error 1.31 |
| TENA Identifi With Sensor Wear Data | Wet Events Per 24 Hours | Days 7-9 | 7.05 events per 24 hours | Standard Error 1.31 |
| TENA Identifi Without Sensor Wear Data | Wet Events Per 24 Hours | Days 1-3 | 5.75 events per 24 hours | Standard Error 1.39 |
| TENA Identifi Without Sensor Wear Data | Wet Events Per 24 Hours | Days 7-9 | 5.45 events per 24 hours | Standard Error 1.39 |
Secondary
Number of Brief Changes Per 24 Hours
The number of brief changes per 24 hours, intervention versus control
Time frame: 6 days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| TENA Identifi With Sensor Wear Data | Number of Brief Changes Per 24 Hours | Days 1-3 | 3.25 events per 24 hours | Standard Error 0.26 |
| TENA Identifi With Sensor Wear Data | Number of Brief Changes Per 24 Hours | Days 7-9 | 3.08 events per 24 hours | Standard Error 0.26 |
| TENA Identifi Without Sensor Wear Data | Number of Brief Changes Per 24 Hours | Days 1-3 | 2.54 events per 24 hours | Standard Error 0.28 |
| TENA Identifi Without Sensor Wear Data | Number of Brief Changes Per 24 Hours | Days 7-9 | 2.52 events per 24 hours | Standard Error 0.28 |
Secondary
Time Wet Per 24 Hours
Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control
Time frame: 6 days
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| TENA Identifi With Sensor Wear Data | Time Wet Per 24 Hours | Days 1-3 | 10.69 hours per 24 hours | Standard Error 1.83 |
| TENA Identifi With Sensor Wear Data | Time Wet Per 24 Hours | Days 7-9 | 10.24 hours per 24 hours | Standard Error 1.83 |
| TENA Identifi Without Sensor Wear Data | Time Wet Per 24 Hours | Days 7-9 | 8.94 hours per 24 hours | Standard Error 2.01 |
| TENA Identifi Without Sensor Wear Data | Time Wet Per 24 Hours | Days 1-3 | 9.70 hours per 24 hours | Standard Error 2.01 |