Wicked Smart Pad: Washable Sensorized Bedding for the Prevention and Detection of Moisture Events

PROJECT SUMMARY Due to decreased mobility, deterioration in activities of daily living, and neurological decline that contributes to loss of bladder control, incontinence is a leading comorbidity for those individuals suffering from Alzheimer’s disease and related dementias (ADRD). Individuals with incontinence are susceptible to the development of pressure ulcers (PUs) and other iatrogenic skin injuries that are often regarded as an inevitable part of aging. Incontinence and related dermatological conditions are a significant comorbidity in senior residents with PUs occurring in nearly 40% of advanced dementia patients. As such, maintaining skin integrity in ADRD patients is an ever-present challenge for healthcare providers and caregivers as well as a significant financial burden. Early detection of moisture events mitigates the complications associated with incontinence, improving the quality-of- care patients receive. To address this need, Wicked Sheets, a Kentucky-based, woman-owned business, has developed the Wicked Smart Pad (WSP) -- a washable and reusable, sensorized bedding pad system. It alerts caregivers when a moisture event occurs via wireless communication, collecting vital information to support the care team. In Phase I, the PI and the collaborating site, Atria Park of Great Neck, New York, evaluated the feasibility and usability of our WSP system, its acceptability by care staff and residents alike, and identified key areas for improvement in their initial design. Our team tested 200 WSPs at three locations involving 36 memory care residents for 8-12 weeks each. Use of the WSP real-time alerts allowed staff to establish the Incontinence Response Rate (IRR) as a metric for care delivery; reduced average spillovers to a single event in six weeks; reduced 35-minute bedding changes to a five-minute exchange of the WSP; and coincided with zero observed bedsores in participating residents. We also constructed the Wicked Smart dashboard – an interface for memory care staff enabling them to view moisture event data over several months for any resident – to improve operational intelligence and curation of data-driven staffing and resident care plans. In this Phase II proposal, we aim to address challenges identified during our pilot study, namely the need for improved hardware design and expanded compatibility of the accompanying software, by revising our hardware and software systems for improved integration with care staff needs and to meet industry and regulatory standards. Subsequently, we aim to validate our improved designs and assess the efficacy of the WSP system in reducing incontinence events by informing resident care schedules through a multi-site single-arm clinical study in partnership with Atria Senior Living. Completion of Phase II will result in a commercially viable WSP platform ready for deployment in memory care facilities that can reduce the burden of incontinence care, reduce the incidence of PUs and other incontinence related skin conditions, and improve resident quality of life.