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Randomized Controlled Trial
. 2023 Feb 3;24(1):80.
doi: 10.1186/s13063-022-07031-z.

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

Muyibat Omotunde  1 , Fredrik Agholme  2 , Arne Böhling  3 , Nicole Huige  2 , Hardy Schweigel  4 , Daniela Hayder-Beichel  5 , Robert Reidy  6 , Adrian Wagg  7
Affiliations
Randomized Controlled Trial

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

Muyibat Omotunde et al. Trials. .

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.

Keywords: Care aide continence care; Caregivers; Digital health technology; Medical device; Nursing homes (long-term care facilities); Older adults; Residents; TENA SmartCare Change Indicator; Urinary incontinence.

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Conflict of interest statement

ASW: research support from Essity Hygiene & Health, AB, Pfizer Corp., speaker honoraria from Urovant Sciences. FA, AB, HS and NH are employees of Essity Hygiene & Health.

RR is an employee of Staburo GmbH, contracted for this trial by Essity Hygiene & Health AB.

MO and DHB: no relevant competing interests.

Figures

Fig. 1
Fig. 1
Components of the SmartCare Change Indicator: The electronic sensor (B) is placed on the outside of the incontinence product and estimates the urine saturation level. Results are displayed via an app and dashboard (A) installed on a mobile derive or desktop computer. C Detailed view on the transmitter which is combined with the sensor strip and placed on the incontinence product
See this image and copyright information in PMC

References

    1. Gibson W, Wagg A. New horizons: urinary incontinence in older people. Age Ageing. 2014;43(2):157–163. doi: 10.1093/ageing/aft214. - DOI - PubMed
    1. Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288–294. doi: 10.1002/nau.20668. - DOI - PubMed
    1. Zorn BH, Montgomery H, Pieper K, Gray M, Steers WD. Urinary incontinence and depression. J Urol. 1999;162(1):82–84. doi: 10.1097/00005392-199907000-00020. - DOI - PubMed
    1. Omli R, Skotnes LH, Romild U, Bakke A, Mykletun A, Kuhry E. Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents. Age Ageing. 2010;39(5):549–554. doi: 10.1093/ageing/afq082. - DOI - PubMed
    1. Ostaszkiewicz J. Reframing continence care in care-dependence. Geriatr Nurs. 2017;38(6):520–526. doi: 10.1016/j.gerinurse.2017.03.014. - DOI - PubMed

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