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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209570
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Essity Hygiene and Health AB
Information provided by (Responsible Party):
Insight Therapeutics, LLC

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Care planning using TENA Identifi sensor wear data Other: Care planning without using TENA Identifi sensor wear data Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : August 11, 2018
Actual Study Completion Date : August 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TENA Identifi with sensor wear data
All individuals in this arm will receive care planning using TENA Identifi sensor wear data
Other: 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.

Active Comparator: TENA Identifi without sensor wear data
All individuals in this arm will receive care planning without using TENA Identifi sensor wear data
Other: 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.




Primary Outcome Measures :
  1. Wet Events Per 24 Hours [ Time Frame: 6 days ]
    Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control


Secondary Outcome Measures :
  1. Time Wet Per 24 Hours [ Time Frame: 6 days ]
    Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control

  2. Number of Brief Changes Per 24 Hours [ Time Frame: 6 days ]
    The number of brief changes per 24 hours, intervention versus control



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209570


Locations
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United States, Virginia
Chesapeake Health & Rehabilitation Center
Chesapeake, Virginia, United States, 23320
Norfolk Health & Rehabilitation Center
Norfolk, Virginia, United States, 23504
Insight Therapeutics, LLC
Norfolk, Virginia, United States, 23510
Westminster-Canterbury on Chesapeake Bay
Virginia Beach, Virginia, United States, 23451
Beth Sholom Village
Virginia Beach, Virginia, United States, 23464
Sponsors and Collaborators
Insight Therapeutics, LLC
Essity Hygiene and Health AB
Investigators
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Principal Investigator: Stefan Gravenstein, MD, MPH Brown University
Principal Investigator: H Edward Davidson, PharmD, MPH Insight Therapeutics, LLC
  Study Documents (Full-Text)

Documents provided by Insight Therapeutics, LLC:
Additional Information:
Publications:
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Responsible Party: Insight Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT03209570    
Other Study ID Numbers: INSI-201706
First Posted: July 6, 2017    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Insight Therapeutics, LLC:
urinary incontinence, nursing home
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Zinc Oxide
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs