UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041716 |
|---|---|
| Receipt number | 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 | 2024/03/24 19:18:47 |
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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
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
hiraik@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
昭和大学藤が丘病院(神奈川県)
昭和大学江東豊洲病院(東京)
山梨赤十字病院(山梨)
荏原病院(東京)
旭中央病院(千葉)
亀田総合病院(千葉)
茨城東病院(茨城)
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
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047613
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