UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062459 |
|---|---|
| Receipt number | R000071486 |
| Scientific Title | Death and worsening of long-term care certification level after acute hospitalization for infection: an active-comparator matched cohort study using the JMDC late-elderly claims database |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 20:07:21 |
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Basic information
Public title
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
Acronym
Infection Post-Hospitalization Prognosis Study (JMDC)
Scientific Title
Death and worsening of long-term care certification level after acute hospitalization for infection: an active-comparator matched cohort study using the JMDC late-elderly claims database
Scientific Title:Acronym
Infection Post-Admission Matched Cohort Study (JMDC)
Region
| Japan |
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 specialty
| Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Observational prognostic comparison. An epidemiological study evaluating whether acute hospitalization for infection, compared with hospitalization for other acute conditions, is associated with the prognosis of death and worsening of long-term care need.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A composite primary outcome within 365 days of the admission date (index): all-cause death or worsening of long-term care certification level (assessed at index plus 12 calendar months). The time scale is monthly discrete time using Aalen-Johansen cumulative incidence functions. For indeterminate cases (0.8%), a primary analysis with inverse-probability-of-censoring weighting and upper/lower bound analyses (all-event vs all-non-event) are performed. The primary measure is the risk difference (95% CI).
Key secondary outcomes
Secondary: the 180-day composite outcome, death alone, worsening of long-term care level alone, and infection-subtype analyses (COVID-19, aspiration pneumonia, other pneumonia, upper/lower urinary tract infection, skin and soft-tissue infection, infectious enteritis, unknown source, etc.). Sensitivity analyses: restriction to episodes with an emergency-admission proxy, facility fixed effects and within-facility matching, an upper-bound analysis for missing discharge dates, complete-observer analysis, and an extended population B (care levels 3-5).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
166712
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
kutsuna@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
Homepage URL
kutsuna@hp-infect.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The University of Osaka Hospital, Ethical Review Board
Address
2-15, Yamadaoka, Suita city
Tel
0836-6879-5111
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学大学院医学系研究科 感染制御学 / The University of Osaka, Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an active-comparator matched cohort study using the JMDC late-elderly claims database (medical claims April 2018 to March 2025; monthly long-term care level April 2019 to March 2025; index period October 2019 to March 2024; follow-up end 31 March 2025). Acute hospitalization for infection among adults aged 75 years and older is compared with a comparator group (heart failure exacerbation, acute coronary syndrome, gastrointestinal bleeding, etc.), anchored at the admission date, using one-to-one optimal propensity-score matching, and a 365-day composite of death or worsening of long-term care level is evaluated. This is a prospective registration performed before the between-group comparison of the primary outcome. Existing anonymized data are analysed after institutional review board approval.
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071486
