UMIN-CTR Clinical Trial

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

pneumonia

Classification by specialty

Medicine in general	Pneumology	Geriatrics
Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Jikei University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2022

Year

12

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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