UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049686
Receipt number R000056591
Scientific Title Multidisciplinary Observational Study with Artificial Intelligence on Diagnosis, Prognosis Prediction, and Treatment of Pneumonia for the Older Adults
Date of disclosure of the study information 2022/12/04
Last modified on 2022/12/05 05:21:14

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Basic information

Public title

Multidisciplinary Observational Study with Artificial Intelligence on Diagnosis, Prognosis Prediction, and Treatment of Pneumonia for the Older Adults

Acronym

Multidisciplinary Observational Study with Artificial Intelligence on Diagnosis, Prognosis Prediction, and Treatment of Pneumonia for the Older Adults

Scientific Title

Multidisciplinary Observational Study with Artificial Intelligence on Diagnosis, Prognosis Prediction, and Treatment of Pneumonia for the Older Adults

Scientific Title:Acronym

Multidisciplinary Observational Study with Artificial Intelligence on Diagnosis, Prognosis Prediction, and Treatment of Pneumonia for the Older Adults

Region

Japan


Condition

Condition

pneumonia

Classification by specialty

Medicine in general Pneumology Geriatrics
Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary objective of this study is to verify whether artificial intelligence analysis can predict life expectancy and optimize treatment for older patients with pneumonia (including COVID-19) based on the information collected in the electronic medical record (EMR) .

Basic objectives2

Others

Basic objectives -Others

The secondary objective of this study is to use artificial intelligence analysis to identify factors related to pneumonia treatment and physical and cognitive function prognosis in older patients with pneumonia (incl. COVID-19).

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Severity (use of ventilator/noninvasive positive pressure ventilation with or without oxygen) and prognosis (survival and death of patients with pneumonia) 30 days after onset of pneumonia

Key secondary outcomes

(1) Clinical characteristics of causative organisms
(2) Clinical response to treatment according to the type of antimicrobial agent (body temperature chart and blood sample results to determine whether the patient is cured)
(3) Length of hospitalization (days)
(4) Functional prognosis (alternative nutrition, type of walking aids, cognitive symptoms, facility admission)
(5) Sarcopenia and osteoporosis (dual energy X-ray absorptiometry DEXA, bioimpedance method BIA)
(6) Agreement between artificial intelligence (AI) and physician prognosis (primary endpoint, functional prognosis)
(7) AI assisted diagnosis of chest X-ray


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

65 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

Pneumonia group
(1) Patients with a history of pneumonia in the past
(2) Those who are 65 years of age or older at the time of onset of pneumonia.
(3) Those who goes to hospital regularly or day-care center.

Non-pneumonia group
(1) Those who have no history of pneumonia in the past.
(2) Patients who are 65 years old or older at the time of their last visit to a hospital or nursing care facility.
(3) Those who goes to hospital regularly or day-care center.

Key exclusion criteria

(1) Persons who refuse to participate in the research

Target sample size

9000


Research contact person

Name of lead principal investigator

1st name Naoto
Middle name
Last name Ozaki

Organization

The Jikei University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

105-8471

Address

3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

nozakiame@jikei.ac.jp


Public contact

Name of contact person

1st name Naoto
Middle name
Last name Ozaki

Organization

The Jikei University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

105-8471

Address

3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

nozakiame@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Jikei University School of Medicine

Address

3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo

Tel

03-3433-1111

Email

rinri@jikei.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

東京大学(東京都),キッコーマン総合病院(千葉県),国際医療福祉大学市川病院(千葉県), 小張総合病院(千葉県), 野田病院(千葉県), 横浜国立大学(神奈川県), 季美の森リハビリテーション病院(千葉県), 日本IBM(東京都)


Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 04 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

Open public recruiting

Date of protocol fixation

2022 Year 10 Month 25 Day

Date of IRB

2022 Year 10 Month 25 Day

Anticipated trial start date

2022 Year 10 Month 25 Day

Last follow-up date

2026 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a multi-institutional observational study to examine whether artificial intelligence analysis of medical records can predict life expectancy, severity of illness, functional prognosis, and appropriate treatment recommendations in older patients with pneumonia.

The following information is to be collected:
Clinical information and laboratory results of pneumonia patients will be obtained from the electronic medical records of participating institutions.
The clinical data will include basic information such as age, gender, height, weight, body temperature, race (place of birth of the patient and one's parents), community-acquired infection, nosocomial infection, past medical history, complications, length of hospitalization, blood data, therapeutic drugs, chest X-ray, CT, MRI, DEXA, BIA and other laboratory records, clinical response to treatment, vital sign(temperature, blood pressure, oxygenation, etc.) ,complications, severity of illness, whether or not a ventilator was used, invasive mechanical ventilation (with or without intubation), duration of intubation, frequency of use of vasopressors or renal replacement therapy, outcome (survival or death), presence of alternative nutrition (gastrostomy, central venous nutrition, etc.), duration of hospitalization, cognitive function assessment, muscle strength assessment (grip strength, knee extension muscle strength), gait function evaluation, long-term care insurance related records (attending physician's opinion, long-term care certification results), history of hospitalization for pneumonia, history of COVID-19, history of medical conditions (internal diseases, bone fracture, Parkinson's disease, cerebrovascular disease, dementia), number of hospitalizations, alternative nutrition, type of walking aid, whether the patient is institutionalized, etc.


Management information

Registered date

2022 Year 12 Month 04 Day

Last modified on

2022 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056591


Research Plan
Registered date File name

Research case data specifications
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Research case data
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