A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents
Abstract Background Urinary continence care for residents of nursing homes who are unable to communicate their toileting needs usually involves care aides manually checking continence products (pads) to determine the level of urine saturation prior to changing. The TENA SmartCare Change Indicator is...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-07031-z |
| _version_ | 1828041413838766080 |
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| author | Muyibat Omotunde Fredrik Agholme Arne Böhling Nicole Huige Hardy Schweigel Daniela Hayder-Beichel Robert Reidy Adrian Wagg |
| author_facet | Muyibat Omotunde Fredrik Agholme Arne Böhling Nicole Huige Hardy Schweigel Daniela Hayder-Beichel Robert Reidy Adrian Wagg |
| author_sort | Muyibat Omotunde |
| collection | DOAJ |
| description | Abstract Background Urinary continence care for residents of nursing homes who are unable to communicate their toileting needs usually involves care aides manually checking continence products (pads) to determine the level of urine saturation prior to changing. The TENA SmartCare Change Indicator is a medical device which estimates urine saturation and notifies caregivers of the optimal time for pad changes. This study will seek to examine the effect of the TENA SmartCare Change Indicator on urinary continence care efficiency and skin health, in comparison to usual care. Methods This cluster randomized controlled trial (NCT05247047) involving older nursing home residents with urinary incontinence unable to consistently indicate their toileting needs, and their care aides, will compare technology-based and usual continence care over a period of 8 weeks. Co-primary endpoints of superiority in continence care efficiency and non-inferiority in the maintenance of skin health will be assessed. Secondary outcomes will examine the resident quality of life, sleep quality, responsive behaviours, changes in pad use and leakage episodes outside the pad. Change in care aide work engagement, job satisfaction and rushed tasks will be assessed. Benefits and challenges with the use of the device for continence care will be identified from the perspectives of the care staff. Discussion Urinary continence assessment and care in nursing homes is reported as suboptimal and threatening to dignity. Data on the utility and effect of technological solutions for improving urinary continence care are few and conflicting. If shown effective, this technological solution has the potential to improve the care for older residents and improve the working lives of caregiving staff who look after this most vulnerable section of the population. Trial registration ClinicalTrials.gov NCT05247047. Registration date is Feb 18, 2022 |
| first_indexed | 2024-04-10T17:15:45Z |
| format | Article |
| id | doaj.art-070309dfd0e24d33b6bc478b09d84c47 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-10T17:15:45Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-070309dfd0e24d33b6bc478b09d84c472023-02-05T12:22:55ZengBMCTrials1745-62152023-02-0124111510.1186/s13063-022-07031-zA post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residentsMuyibat Omotunde0Fredrik Agholme1Arne Böhling2Nicole Huige3Hardy Schweigel4Daniela Hayder-Beichel5Robert Reidy6Adrian Wagg7Division of Geriatric Medicine, Department of Medicine, University of AlbertaEssity Hygiene & Health ABEssity/BSN Medical GmbHEssity Hygiene & Health ABEssity/BSN Medical GmbHDepartment of Health, Hochschule Neiderrhein-University of Applied SciencesStaburo GmbHDivision of Geriatric Medicine, Department of Medicine, University of AlbertaAbstract Background Urinary continence care for residents of nursing homes who are unable to communicate their toileting needs usually involves care aides manually checking continence products (pads) to determine the level of urine saturation prior to changing. The TENA SmartCare Change Indicator is a medical device which estimates urine saturation and notifies caregivers of the optimal time for pad changes. This study will seek to examine the effect of the TENA SmartCare Change Indicator on urinary continence care efficiency and skin health, in comparison to usual care. Methods This cluster randomized controlled trial (NCT05247047) involving older nursing home residents with urinary incontinence unable to consistently indicate their toileting needs, and their care aides, will compare technology-based and usual continence care over a period of 8 weeks. Co-primary endpoints of superiority in continence care efficiency and non-inferiority in the maintenance of skin health will be assessed. Secondary outcomes will examine the resident quality of life, sleep quality, responsive behaviours, changes in pad use and leakage episodes outside the pad. Change in care aide work engagement, job satisfaction and rushed tasks will be assessed. Benefits and challenges with the use of the device for continence care will be identified from the perspectives of the care staff. Discussion Urinary continence assessment and care in nursing homes is reported as suboptimal and threatening to dignity. Data on the utility and effect of technological solutions for improving urinary continence care are few and conflicting. If shown effective, this technological solution has the potential to improve the care for older residents and improve the working lives of caregiving staff who look after this most vulnerable section of the population. Trial registration ClinicalTrials.gov NCT05247047. Registration date is Feb 18, 2022https://doi.org/10.1186/s13063-022-07031-zCaregiversCare aide continence careResidentsOlder adultsNursing homes (long-term care facilities)TENA SmartCare Change Indicator |
| spellingShingle | Muyibat Omotunde Fredrik Agholme Arne Böhling Nicole Huige Hardy Schweigel Daniela Hayder-Beichel Robert Reidy Adrian Wagg A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents Trials Caregivers Care aide continence care Residents Older adults Nursing homes (long-term care facilities) TENA SmartCare Change Indicator |
| title | A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents |
| title_full | A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents |
| title_fullStr | A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents |
| title_full_unstemmed | A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents |
| title_short | A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents |
| title_sort | post market cluster randomized controlled trial of the effect of the tena smartcare change indicator™ on urinary continence care efficiency and skin health in older nursing home residents |
| topic | Caregivers Care aide continence care Residents Older adults Nursing homes (long-term care facilities) TENA SmartCare Change Indicator |
| url | https://doi.org/10.1186/s13063-022-07031-z |
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