Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062459) titled 'A study comparing the 1-year risk of death or worsening of long-term care need after acute hospitalization for infection versus hospitalization for conditions such as heart failure or acute coronary syndrome, among older adults, using the JMDC late-elderly claims database' on Aug. 3.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - Acute hospitalization for infection among late-elderly adults (comparators are acute hospitalizations for heart failure exacerbation, acute coronary syndrome, gastrointestinal bleeding, etc.). Outcomes are death and worsening of long-term care certification level. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using the JMDC late-elderly claims database, to compare, in an active-comparator matched cohort design anchored at the admission date, patients aged 75 years and older acutely hospitalized for infection with a comparator group similarly hospitalized (heart failure exacerbation, acute coronary syndrome, gastrointestinal bleeding, etc.), and to estimate the 365-day risk of a composite outcome of all-cause death or worsening of long-term care certification level. One-to-one optimal propensity-score matching is used, with the risk difference as the primary measure. This registration is performed before conducting the between-group comparison of the primary outcome. Basic objectives2 - Others

Eligibility: Age-lower limit - 75 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Adults aged 75 years and older in the JMDC late-elderly database (medical claims April 2018 to March 2025; monthly long-term care level April 2019 to March 2025). (2) A first acute hospitalization for a target infection or a comparator condition during the index period (1 October 2019 to 31 March 2024). (3) At least 365 days of continuous medical enrollment before the admission date (index). (4) A monthly long-term care level record in every one of the 6 calendar months before index (180-day care observation). (5) Baseline long-term care level (month before index) from no certification up to care level 2 (codes 0-4). (6) No upward month-over-month change in care level in the 6 calendar months before index (improvement allowed; a new certification counts as an upward change). Key exclusion criteria - (1) Baseline long-term care level of care level 3-5 (excluded from the main cohort; examined separately as extended population B). (2) An upward change in care level in the 6 calendar months before index. (3) Failure to meet 365-day medical or 180-day care observation. (4) In the comparator group, any target infection code among admission-time diagnoses (excluding post-admission onset), to define a clean comparator. (5) Episodes with only suspected diagnoses. Target Size - 166712

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 08 Month 03 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071486

Disclaimer: Curated by HT Syndication.