search
Back to results

The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TENA SmartCare Change Indicator
Sponsored by
Essity Hygiene and Health AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence).
  2. Subject is a permanent (intended length of stay four months or longer) resident of the nursing home.
  3. Subject is unable to consistently communicate toileting needs.
  4. Subject is unable to successfully toilet and change the pad without assistance.
  5. Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) and TENA Pants (Underwear) absorbing products for the study.
  6. Subject has a waist size appropriate to the available sizes of incontinence products.
  7. Subject is willing and able to provide informed consent to participate or if unable to provide consent have a legal representative who is willing and able to provide informed consent on behalf of the subject.
  8. Subject is part of a continence care regimen, defined as "check and change", using any method.
  9. If applicable, subject is to be on a stable regimen of medications for urinary incontinence
  10. Subject is over 18 years of age.

Exclusion Criteria:

  1. Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
  2. Subject has severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection).
  3. Subject has any type of indwelling or external urinary catheter(s).
  4. Subject is anuric.
  5. Subject is managed using another automated or digital health technology incontinence management device.
  6. Subject has responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
  7. Subject has any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
  8. Subject has a life expectancy of fewer than 3 months or be receiving palliative or terminal care.
  9. Subject has participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
  10. Subject is dependent on either alcohol or recreational drugs.

Sites / Locations

  • University of AlbertaRecruiting
  • Hochschule Niederrhein University of Applied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Device

Control

Arm Description

Clusters in this arm will start using the device and use it for 6 weeks.

Clusters in this arm will not receive the device it will continue with usual care with no changes.

Outcomes

Primary Outcome Measures

Care Efficiency score
Care efficiency is the weighted sum of the pre-defined care events divided by the number of recorded diary days of the subject in question. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is collected daily via the study diary.
Daily Skin Health score
Skin health score is based on skin health grades that have been reported by the caregiver in the study diary. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.

Secondary Outcome Measures

Number of continence care product checks
From the study diary the number of checks of absorbing incontinence products is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Number of continence care product changes
From the study diary the number of changes of absorbing incontinence products is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Number of continence care toilet visits
From the study diary the number of toilet visits is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Number of continence care clothing changes
From the study diary the number of clothing changes due to leakages is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Number of continence care bed linen changes
From the study diary the number of bed linen changes due to leakages is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
The time spent on continence care episodes
From the study diary the total time spent on continence care is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Skin health score
Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit.
Quality of life and level of utility
Measured using the EQ-5D-5L questionnaire at study completion visit and compared to the end of baseline visit.
Quality of life according to the QoL-AD
Measured and scored at completion visit and compared to the end of baseline visit.
Level of agitation and responsive behavior.
Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit.
Number of sleep interruptions due to continence care
From the study diary the number of sleep interruptions are retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Total absorption value
From the study diary the type, number and absorption value of the incontinence care product is retrieved. This data is used to create a total absorption measure. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Caregiver work engagement
Using the UWES questionnaire the work engagement of caregivers are measured at a cluster's end-of-trial visit and compared to the end of baseline visit.
Caregiver work conditions
Measured using the organizational headroom questionnaire at a cluster's end-of-trial visit and compared to the end of baseline visit.
Time spent in a saturated continence care product
Data from study diary used to retrieve the total hours that occur between an observed fully saturated product and the change of the saturated product. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Number of unnecessary checks.
Data from study diary used to retrieve the number of unnecessary checks/changes. An unnecessary check/change is defined as, an activity line where a product check was performed but no product change occurred or an activity line where a product change occurred but neither a fully nor partially saturated product was indicated. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared
Qualitative data on implementation, uptake, opportunities and barriers to use.
Response to interviews with caregivers, coded by the investigator and collated into trends and themes. Conducted after completion of study for subjects.
Safety data for the device.
Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD).

Full Information

First Posted
February 9, 2022
Last Updated
August 3, 2023
Sponsor
Essity Hygiene and Health AB
search

1. Study Identification

Unique Protocol Identification Number
NCT05247047
Brief Title
The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities
Official Title
A Post-market Cluster Randomized Controlled Trial of the Effect of the TENA SmartCare Change Indicator on Continence Care Efficiency and Skin Health in Long Term Care Facilities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essity Hygiene and Health AB

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator when used in a nursing home setting.
Detailed Description
The TENA SmartCare Change Indicator is intended for use on individuals suffering from Urinary Incontinence who are cared for in a nursing home environment, by one or more professional caregivers. The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to increase continence care efficiency at the nursing home by reducing the time needed in daily handling of absorbing incontinence products. Furthermore, this reduction in needed care does not have a detrimental effect on skin health. Secondarily, the investigation have multiple outcomes regarding number of checks, changes and leaks and also quality of life for subjects and qualitative measures for caregivers. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
Clusters in this arm will start using the device and use it for 6 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Clusters in this arm will not receive the device it will continue with usual care with no changes.
Intervention Type
Device
Intervention Name(s)
TENA SmartCare Change Indicator
Intervention Description
The intervention is a medical device system that consists of a reusable electronic sensor and an application installed on one or more smart phones. The device estimates the saturation level of an absorbing incontinence product used by a study subject. The device is non-invasive and does not have any effect on the function of the absorbing incontinence product.
Primary Outcome Measure Information:
Title
Care Efficiency score
Description
Care efficiency is the weighted sum of the pre-defined care events divided by the number of recorded diary days of the subject in question. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is collected daily via the study diary.
Time Frame
10 weeks.
Title
Daily Skin Health score
Description
Skin health score is based on skin health grades that have been reported by the caregiver in the study diary. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Secondary Outcome Measure Information:
Title
Number of continence care product checks
Description
From the study diary the number of checks of absorbing incontinence products is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Number of continence care product changes
Description
From the study diary the number of changes of absorbing incontinence products is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Number of continence care toilet visits
Description
From the study diary the number of toilet visits is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Number of continence care clothing changes
Description
From the study diary the number of clothing changes due to leakages is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Number of continence care bed linen changes
Description
From the study diary the number of bed linen changes due to leakages is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
The time spent on continence care episodes
Description
From the study diary the total time spent on continence care is retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Skin health score
Description
Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit.
Time Frame
10 weeks.
Title
Quality of life and level of utility
Description
Measured using the EQ-5D-5L questionnaire at study completion visit and compared to the end of baseline visit.
Time Frame
10 weeks.
Title
Quality of life according to the QoL-AD
Description
Measured and scored at completion visit and compared to the end of baseline visit.
Time Frame
10 weeks.
Title
Level of agitation and responsive behavior.
Description
Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit.
Time Frame
10 weeks.
Title
Number of sleep interruptions due to continence care
Description
From the study diary the number of sleep interruptions are retrieved. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Total absorption value
Description
From the study diary the type, number and absorption value of the incontinence care product is retrieved. This data is used to create a total absorption measure. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks.
Title
Caregiver work engagement
Description
Using the UWES questionnaire the work engagement of caregivers are measured at a cluster's end-of-trial visit and compared to the end of baseline visit.
Time Frame
10 weeks.
Title
Caregiver work conditions
Description
Measured using the organizational headroom questionnaire at a cluster's end-of-trial visit and compared to the end of baseline visit.
Time Frame
10 weeks.
Title
Time spent in a saturated continence care product
Description
Data from study diary used to retrieve the total hours that occur between an observed fully saturated product and the change of the saturated product. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time Frame
10 weeks
Title
Number of unnecessary checks.
Description
Data from study diary used to retrieve the number of unnecessary checks/changes. An unnecessary check/change is defined as, an activity line where a product check was performed but no product change occurred or an activity line where a product change occurred but neither a fully nor partially saturated product was indicated. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared
Time Frame
10 weeks
Title
Qualitative data on implementation, uptake, opportunities and barriers to use.
Description
Response to interviews with caregivers, coded by the investigator and collated into trends and themes. Conducted after completion of study for subjects.
Time Frame
10 weeks.
Title
Safety data for the device.
Description
Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD).
Time Frame
10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence). Subject is a permanent (intended length of stay four months or longer) resident of the nursing home. Subject is unable to consistently communicate toileting needs. Subject is unable to successfully toilet and change the pad without assistance. Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) and TENA Pants (Underwear) absorbing products for the study. Subject has a waist size appropriate to the available sizes of incontinence products. Subject is willing and able to provide informed consent to participate or if unable to provide consent have a legal representative who is willing and able to provide informed consent on behalf of the subject. Subject is part of a continence care regimen, defined as "check and change", using any method. If applicable, subject is to be on a stable regimen of medications for urinary incontinence Subject is over 18 years of age. Exclusion Criteria: Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator. Subject has severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection). Subject has any type of indwelling or external urinary catheter(s). Subject is anuric. Subject is managed using another automated or digital health technology incontinence management device. Subject has responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical. Subject has any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator. Subject has a life expectancy of fewer than 3 months or be receiving palliative or terminal care. Subject has participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation. Subject is dependent on either alcohol or recreational drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Agholme, PhD
Phone
+46730323634
Email
fredrik.agholme@essity.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Böhling, PhD
Phone
+4915221425063
Email
arne.bohling@essity.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Wagg, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Wagg, MD
Phone
+17809069112
Email
adrian.wagg@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Adrian Wagg, MD
Facility Name
Hochschule Niederrhein University of Applied Sciences
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Hayder-Beichel, PhD
Phone
+4921518226755
Email
Daniela.Hayder-Beichel@hs-niederrhein.de
First Name & Middle Initial & Last Name & Degree
Daniela Hayder-Beichel, PhD

12. IPD Sharing Statement

Learn more about this trial

The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities

We'll reach out to this number within 24 hrs