Digital assistance systems in the field of incontinence care for individuals in need of long-term care (EASY): study protocol of a stratified randomised controlled trial

BACKGROUND: In general, urinary and faecal incontinence is a multifaceted problem that is associated with increasing burdens for those affected, a massive impairment of quality of life and economic consequences. Incontinence is associated with a high level of shame, which in particular reduces the self-esteem of those being incontinent and leads to additional vulnerability. Those affected by incontinence often perceive incontinence and the care they receiveas humiliating, hence they can no longer control their own urination; nursing care and cleansing support then lead to additional dependency. People with incontinence in need of care not uncommonly experience a poor communication and many taboos surrounding the issue as well as the use of force when incontinence products are changed. AIMS AND METHODS: This RCT aims to validate the benefits of using a digital assistance system to optimise incontinence care and to enable statements concerning the effect of the assistance technology on nursing and social structures and processes as well as on the quality of life from the perspective of the person in need of care. In a two-arm, stratified, randomised, controlled interventional study, primarily incontinence-affected residents of four inpatient nursing facilities will be examined (n = 80). One intervention group will be equipped with a sensor-based digital assistance system, which will transmit care-related information to the nursing staff (via smartphone). The collected data will be compared to the data of the control group. Primary endpoints are falls occurring; secondary endpoints are quality of life and sleep, sleep disturbances and material consumption. In addition, nursing staff (n = 15–20) will be interviewed regarding the effects, experience, acceptance and satisfaction. DISCUSSION: The RCT aims at the applicability and effect of assistance technologies on nursing structures and processes. It is assumed that, amongst other things, this technology may lead to a reduction of unnecessary checks and material changes, an improvement of life quality, an avoidance of sleep disturbances and thus an improvement of sleep quality as well as to a reduced risk of falling for people with incontinence in need of care. The further development of incontinence care systems is of social interest as this offers the prospect of improving the quality of care for nursing home residents with incontinence. TRAIL REGISTRATION: Approval of the RCT is granted by the Ethics Committee at the University of Applied Sciences Neubrandenburg (Reg.-Nr.: HSNB/190/22). This RCT is registered at the German Clinical Trials Register on July 8(th), 2022, under the identification number DRKS00029635.