Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062365) titled 'Early detection, prevention, and evaluation of treatment, care processes, and outcomes regarding delirium using sensing devices in acute care hospitals' on July 28.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Osaka Medical and Pharmaceutical University

Condition: Condition - Individuals aged 20 or older at high risk of delirium Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To conduct process and outcome evaluations regarding the use of sensing devices for the prevention, treatment, and care of delirium, based on the Consolidated Framework for Implementation Research. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In this study, we will implement early intervention care for delirium based on data obtained from sensing devices worn by hospitalized patients. Data collection will involve the use of sleep sensors and Fitbit devices, which patients will wear from the time consent is obtained until discharge. Terminals displaying visualized data from the sleep sensors will be installed for ward staff to utilize in providing early intervention care.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Individuals aged 20 or older at the time of registration who are at high risk of delirium 2.Individuals deemed suitable for the installation of sleep monitoring equipment and the wearing of a Fitbit, based on the judgment of a physician or nurse 3.Individuals admitted for an overnight stay or longer to the Department of Psychiatry/Neuropsychiatry, Department of Neurosurgery, or Department of Endovascular Neurosurgery Key exclusion criteria - 1.Individuals unable to use sleep monitoring devices or Fitbits due to suicide attempts or their medical condition 2.Individuals unable to use wearable devices due to skin irritation or similar issues Target Size - 300

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 05 Month 19 Day Date of IRB - 2026 Year 05 Month 19 Day Anticipated trial start date - 2026 Year 07 Month 06 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071371

Disclaimer: Curated by HT Syndication.