Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Clusters in this arm will start using the device and use it for 6 weeks. |
|
| Control | No Intervention | Clusters in this arm will not receive the device it will continue with usual care with no changes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENA SmartCare Change Indicator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 presented as average daily care efficiency score (min/day). Data is collected daily via the study diary. | 10 weeks. |
| Daily Skin Health score | Skin health score is based on skin health grades (from 0, no skin problems to 4, very seveer skin problems) 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. Data is presented as average daily skin health score. | 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Data is presented as average daily number of checks. | 10 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Wagg, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2P4 | Canada | ||
| Hochschule Niederrhein University of Applied Sciences |
Not provided
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Cluster
Not provided
Not provided
Not provided
Not provided
|
| 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. Data is presented as average daily number of changes. |
| 10 weeks. |
| 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. Data is presented as average daily number of toilet visits. | 10 weeks. |
| 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. Data is presented as average daily number of clothing changes. | 10 weeks. |
| 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. Data is presented as average daily number of linen changes. | 10 weeks. |
| 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. Data is presented as average daily time spent on continence care. | 10 weeks. |
| Skin health score | Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit. | 10 weeks. |
| 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. | 10 weeks. |
| Quality of life according to the QoL-AD | Measured and scored at completion visit and compared to the end of baseline visit. | 10 weeks. |
| Level of agitation and responsive behavior. | Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit. | 10 weeks. |
| 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. Data is presented as average daily number of interruptions. | 10 weeks. |
| 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. | 10 weeks. |
| 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. | 10 weeks. |
| 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. | 10 weeks. |
| 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. Data is presented as average daily time spent in the saturated product. | 10 weeks |
| 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. Data is presented as average daily number of checks/changes. | 10 weeks |
| 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. | 10 weeks. |
| 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). | 10 weeks. |
| Krefeld |
| 47805 |
| Germany |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |