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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041716
Receipt No. R000047613
Scientific Title survey on perceptions of pneumonia among family members and physicians of pneumonia patients who need hospitalization
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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Basic information
Public title survey on perceptions of pneumonia among family members and physicians of pneumonia patients who need hospitalization
Acronym Survey on the perceptions of pneumonia family members and doctors
Scientific Title survey on perceptions of pneumonia among family members and physicians of pneumonia patients who need hospitalization
Scientific Title:Acronym Survey on the perceptions of pneumonia family members and doctors
Region
Japan

Condition
Condition Pneumonia
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate whether there are differences in perceptions of pneumonia between families and doctors of pneumonia patients who need hospitalization.
Basic objectives2 Others
Basic objectives -Others Survey of the degree of understanding of disease among patient families and doctors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigating gaps in patient survival between physicians and families who received informed consent.
Key secondary outcomes Investigate whether there is a difference in opinion regarding the number of days patients need to improve and the number of days patients need to be discharged and the physical function of the patient at the time of discharge and the food intake status at the time of discharge and the number of days required to improve the patient from their doctors and their families after receiving IC.
Investigate whether there is a difference in opinion regarding the number of days required to discharge a patient and physical function of the patient at the time of discharge and the food intake status of the patient at the time of discharge and the place of discharge between a doctor and a family before receiving IC.
Investigate whether there is a difference in views on patient survival and the number of days required to improve patients and the number of days required for the patient to be discharged between families before and after receiving IC.
Investigate whether there is a difference in the view of the patient's physical function at discharge from the family before and after receiving IC.
Investigate whether there is a difference in opinion regarding the food intake status of the patient at the time of discharge from the family before and after receiving IC.
Investigate whether there is a difference in views of where the patient is discharged from the family before and after receiving IC.
Analysis of the association of various clinical factors and questionnaires with information on patients' comorbidities, severity, location of treatment when hospitalized, DNAR or not.
Analysis of the association of various clinical factors and questionnaires with information on family's and doctor's HADS-A, HADS-D, recurrence risk of pneumonia, pneumococcal vaccine, and comparison with various clinical factors and questionnaires.

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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Family of patients admitted with pneumonia and their doctor
Key exclusion criteria 1) Patients with advanced malignant tumor.
2) Pregnant patients.
3) Patients with new coronavirus pneumonia.
4) Patients who are disqualified at the discretion of the research doctor.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kuniaki
Middle name
Last name Hirai
Organization Showa University
Division name Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email hiraik@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Kuniaki
Middle name
Last name Hirai
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Respiratory Medicine and Allergology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL 03-3784-8000
Homepage URL
Email hiraik@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
Tel 03-3784-8000
Email m-rinri@ofc.showa-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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 07 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 Enrolling by invitation
Date of protocol fixation
2020 Year 08 Month 18 Day
Date of IRB
2020 Year 08 Month 18 Day
Anticipated trial start date
2020 Year 09 Month 08 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 09 Month 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047613

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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