258 - A post-market, cluster randomized controlled trial of the effect of a TENA Smart Care Change Indicator on continence care efficiency and skin health in nursing homes.
Bibliographic record
Abstract
Hypothesis / aims of study Urinary incontinence (UI) is a highly prevalent condition in older residents of nursing homes. In many it cannot be cured, and management consists of achieving contained incontinence by using appropriate products (pads) maintained by toileting and a check and change regimen; this is often poorly managed [1] . The application of digital health technology devices, like urine saturation sensors, in pads may aid appropriate use of these pads, ensure timely change and improve the quality of delivery of continence care 2 , 3 . This study examined the efficacy and safety of the use of the TENA Smart Care Change Indicator (Change Indicator) device for nursing home residents with UI who were dependent on one or more caregivers to change the pad. Study design, materials and methods Methods: Cluster randomised controlled trial of device use in older nursing home residents with UI unable to consistently indicate their needs for toileting, compared to usual care. The co-primary outcomes were care efficiency, the weighted sum of pad checks, pad changes, toilet visits, clothes changes and linen changes (due to pad leakages), divided by the number of recorded diary days for each resident, reported as an average of the daily scores and change in skin health. Secondary resident and caregiver outcomes were also compared. Results Results: Fourteen sites were recruited, nine of which operated routine check and change regimens. Included care units comprised 108 residents, 53 in the intervention group and 49 in the usual care group, and 83 caregivers (31 usual care, 52 intervention). The median age of residents was 87 (range 59 to 101) years and 21.5 % were male. The change in weighted mean score in care efficiency was reduced (improved) by 30 min/day in the intervention group and 16 min/day in the usual care group (p>0.05). There was no statistically significant difference between groups in change in skin health. There were statistically significant between group improvements in sleep quality and total absorbency of pads used, favouring device use. One device related harm, related to skin health, was reported. Other secondary outcomes are shown in the table. Interpretation of results This comparative pragmatic trial of a device designed to improve the delivery of continence care to older residents of nursing homes resulted in reductions in time spent in continence care by 69 min/day, or a 31% reduction. There was no deterioration in skin health. Given that the study failed to demonstrate its primary outcome, it is difficult to assess the clinical relevance of device use, but use allows more control over efficient delivery of continence care. The reduction in pad use and in the number of sleep interruptions are valuable outcomes. A longer-term implementation and efficacy study is warranted to further investigate the impact of use. Concluding message use of the TENA Smart Sensor device was associated with non statistically significant improements in the efficiency of continence care delivery. Use of the device may well facilitate more predictable continence care. Further work is warranted Download: Download high-res image (165KB) Download: Download full-size image Figure 1 . Table 1. Between group change in secondary outcome variables Funding Essity Hygiene and Health AB Clinical Trial Yes Registration Number ClinicalTrials.gov NCT05247047 RCT Yes Subjects Human Ethics Committee Health Research Ethics Board of University of Alberta (Canadian arm) and the Ethics Committee of the German Society for Nursing Science(German arm). Helsinki Yes Informed Consent Yes
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.015 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".