Trial Outcomes & Findings for A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting (NCT NCT03209570)

NCT ID: NCT03209570

Last Updated: 2019-07-26

Results Overview

Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 6 days
• Results posted on: 2019-07-26

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	24	25
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	10	13

Reasons for withdrawal

Measure	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.	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.
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

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

Baseline characteristics by cohort

Measure	TENA Identifi With Sensor Wear Data n=14 Participants 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.	TENA Identifi Without Sensor Wear Data n=12 Participants 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.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Continuous	84.7 years STANDARD_DEVIATION 14.5 • n=5 Participants	79.4 years STANDARD_DEVIATION 11.8 • n=7 Participants	82.3 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants
Height	64.6 inches STANDARD_DEVIATION 5.2 • n=5 Participants	63.8 inches STANDARD_DEVIATION 3.8 • n=7 Participants	64.2 inches STANDARD_DEVIATION 4.5 • n=5 Participants
BMI	28.2 kg/m^2 STANDARD_DEVIATION 7.23 • n=5 Participants	25.9 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	27.1 kg/m^2 STANDARD_DEVIATION 6.9 • n=5 Participants

PRIMARY outcome

Timeframe: 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).

Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control

Outcome measures

Measure	TENA Identifi With Sensor Wear Data n=14 Participants 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.	TENA Identifi Without Sensor Wear Data n=12 Participants 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.
Wet Events Per 24 Hours Days 1-3	8.11 events per 24 hours Standard Error 1.31	5.75 events per 24 hours Standard Error 1.39
Wet Events Per 24 Hours Days 7-9	7.05 events per 24 hours Standard Error 1.31	5.45 events per 24 hours Standard Error 1.39

SECONDARY outcome

Timeframe: 6 days

Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control

Outcome measures

Measure	TENA Identifi With Sensor Wear Data n=14 Participants 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.	TENA Identifi Without Sensor Wear Data n=12 Participants 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.
Time Wet Per 24 Hours Days 1-3	10.69 hours per 24 hours Standard Error 1.83	9.70 hours per 24 hours Standard Error 2.01
Time Wet Per 24 Hours Days 7-9	10.24 hours per 24 hours Standard Error 1.83	8.94 hours per 24 hours Standard Error 2.01

SECONDARY outcome

Timeframe: 6 days

The number of brief changes per 24 hours, intervention versus control

Outcome measures

Measure	TENA Identifi With Sensor Wear Data n=14 Participants 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.	TENA Identifi Without Sensor Wear Data n=12 Participants 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.
Number of Brief Changes Per 24 Hours Days 7-9	3.08 events per 24 hours Standard Error 0.26	2.52 events per 24 hours Standard Error 0.28
Number of Brief Changes Per 24 Hours Days 1-3	3.25 events per 24 hours Standard Error 0.26	2.54 events per 24 hours Standard Error 0.28

Adverse Events

TENA Identifi With Sensor Wear Data

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

TENA Identifi Without Sensor Wear Data

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	TENA Identifi With Sensor Wear Data n=14 participants at risk 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.	TENA Identifi Without Sensor Wear Data n=12 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Acute hypoxic respiratory failure	7.1% 1/14 • Number of events 1 • Adverse events were collected for 6 days/ two 72hr time periods (randomization through study completion) no additional adverse events were reported by nursing facilities	0.00% 0/12 • Adverse events were collected for 6 days/ two 72hr time periods (randomization through study completion) no additional adverse events were reported by nursing facilities

Other adverse events

Adverse event data not reported

Additional Information

H. Edward Davidson, PharmD, MPH

Insight Therapeutics, LLC

Phone: 7576246040

Email: EDavidson@inther.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place