van Cooten Vivette Jc, Gielissen Marieke Fm, den Hollander Wouter, van Mastrigt Ghislaine Apg, Smeets Odile, Bongers Inge Mb, Boon Brigitte
Academy Het Dorp, Research & Advisory on Technology in Long-term Care, Arnhem, The Netherlands.
Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.
J Med Internet Res. 2025 Jul 31;27:e66389. doi: 10.2196/66389.
People 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.
We 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.
A 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.
In 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.
SCC 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.
ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42555.
生活在寄宿护理机构中的重度智力和多重残疾（PIMD）患者会在预定时间接受失禁护理。这可能导致渗漏或不必要的失禁用品（IM）更换，对患者及其专业护理人员产生负面影响。智能失禁护理（SCC）可在IM需要更换时通知护理人员，可能会解决这些问题并改善个性化护理。
我们旨在评估SCC与常规失禁护理相比的效果。主要结局指标是每周的渗漏次数。次要结局包括每周IM更换次数、失禁护理花费的时间、PIMD患者的生活质量以及护理人员的身体负担。
在荷兰的残疾人寄宿护理机构中进行了一项交错入组、开放标签、整群随机试验。总共招募了165名患有PIMD且失禁且无法表明需要更换IM的参与者，其中156名（94.5%）纳入分析。六家寄宿护理机构参与了研究，并以1:1的比例在整群层面进行随机分组。干预组（82/156，52.6%）接受了12周的SCC。等待名单组（74/156，47.4%）继续接受常规失禁护理。在第0、6和12周收集结局指标，并使用广义线性混合模型进行分析。
在意向性分析中比较两组时，SCC在减少每周渗漏次数方面似乎无效。与干预组相比，等待名单组的渗漏次数意外减少（β系数 = 1.013，95%置信区间0.217 - 1.808；P = 0.01）。SCC在减少每周IM更换次数方面有效（β系数 = -2.005，95%置信区间 -3.303至 -0.707；P = 0.003）。未观察到失禁护理花费时间有显著减少（P = 0.84）。对生活质量或护理人员身体负担没有影响。符合方案分析和完成者分析未改变我们的意向性分析结论。然而，探索性分析表明，对渗漏的反直觉影响可能是由于干预组中一家寄宿护理机构内大多数地点的渗漏增加。将该机构排除在分析之外后发现，之前有利于等待名单组的对渗漏的影响不再显著。与等待名单组相比，干预组IM更换次数的减少显示效应量增加，从Cohen d = -0.34增加到Cohen d = -0.45。
SCC在减少每周渗漏次数方面无效，但减少了每周IM更换次数。我们观察到两组的失禁护理都有所改善。增加对失禁护理的关注，无论是否采用技术手段，都可能导致护理效果改善。需要进一步研究以确定实施SCC最有意义的环境。
ClinicalTrials.gov NCT05481840；https://clinicaltrials.gov/ct2/show/NCT05481840。
国际注册报告识别码（IRRID）：RR2 - 10.2196/42555。
