Effectiveness of Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Cluster Randomized Trial.

backgroundPeople with profound intellectual and multiple disabilities (PIMD) living in residential care facilities receive continence care at scheduled times. This can result in leakage or unnecessary incontinence material (IM) changes, negatively affecting individuals and their professional caregivers. Smart continence care (SCC), which notifies caregivers when IMs require changing, may resolve these issues and improve personalized care.

objectiveWe aimed to evaluate the effects of SCC in comparison with regular continence care. The primary outcome measure was the number of weekly leakages. Secondary outcomes were the number of weekly IM changes, the time spent on continence care, the quality of life of individuals with PIMD, and caregivers' physical burden.

methodsA staggered-entry, open-label, cluster randomized trial was conducted in residential care facilities for people with disabilities in the Netherlands. Overall, 165 participants with PIMD and incontinence who were unable to indicate the need for IM changes were recruited, of whom 156 (94.5%) were included in the analyses. Six residential care facilities participated in the study and were randomized at a cluster level of 1:1. The intervention group (82/156, 52.6%) received SCC for 12 weeks. The waiting-list group (74/156, 47.4%) continued to receive regular continence care. Outcome measures were collected at weeks 0, 6, and 12 and were analyzed using generalized linear mixed models.

resultsIn intention-to-treat analyses comparing both groups, SCC appeared ineffective in reducing weekly leakages. An unexpected reduction in leakages for the waiting-list group compared to the intervention group was revealed (β coefficient=1.013, 95% CI 0.217-1.808; P=.01). SCC was effective in reducing the number of IM changes per week (β coefficient=-2.005, 95% CI -3.303 to -.707; P=.003). No significant reduction in the time spent on continence care (P=.84) was observed. There was no effect on quality of life or improvement in caregivers' physical burden. Per-protocol and completer analyses did not alter our intention-to-treat conclusions. However, exploratory analyses revealed that the counterintuitive effect on leakage may be due to increased leakages at most locations within one residential care facility in the intervention group. The exclusion of this facility from the analyses revealed that the effect on leakage, which had previously favored the waiting-list group, was no longer significant. The reduction in the number of IM changes in the intervention group compared to the waiting-list group showed an increased effect size, from Cohen d=-0.34 to Cohen d=-0.45.

conclusionsSCC was ineffective in reducing the number of weekly leakages, but it reduced the number of weekly IM changes. We observed improvements in continence care in both groups. Increased attention to continence care, with or without technology, may lead to improved care outcomes. Additional research is required to identify the settings in which the implementation of SCC is most meaningful.

trial registrationClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42555.