UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020371 |
|---|---|
| Receipt number | R000023528 |
| Scientific Title | The prospective observational study to evaluate simple swallowing ability in patients with group B or C or D of Nursing and Healthcare Associated Pneumonia (NHCAP) according to the JRS Guidelines for the Management of NHCAP in Adults |
| Date of disclosure of the study information | 2015/12/27 |
| Last modified on | 2023/07/03 18:11:03 |
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Basic information
Public title
The prospective observational study to evaluate simple swallowing ability in patients with group B or C or D of Nursing and Healthcare Associated Pneumonia (NHCAP) according to the JRS Guidelines for the Management of NHCAP in Adults
Acronym
The prospective observational study to evaluate simple swallowing ability in patients with NHCAP group B/C/D according to the JRS Guidelines
Scientific Title
The prospective observational study to evaluate simple swallowing ability in patients with group B or C or D of Nursing and Healthcare Associated Pneumonia (NHCAP) according to the JRS Guidelines for the Management of NHCAP in Adults
Scientific Title:Acronym
The prospective observational study to evaluate simple swallowing ability in patients with NHCAP group B/C/D according to the JRS Guidelines
Region
| Japan |
Condition
Condition
Nursing and Healthcare Associated Pneumonia
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate simple swallowing ability in patients with NHCAP categorized as group B or C or D according to the JRS Guidelines for the Management of NHCAP in Adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapses of pneumonia occurring within 30 days following admission
Key secondary outcomes
30-day mortality
6-month mortality
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients 20 years of age and older
2. Patients with NHCAP categorized as group B or C or D according to the JRS Guidelines for the Management of NHCAP in Adults.
Key exclusion criteria
Patients deemed ineligible judged by the attending physicians for various reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuji |
| Middle name | |
| Last name | Katou |
Organization
Tobata Kyoritsu Hospital
Division name
Department of Respiratory Medicine
Zip code
8040093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu city, Fukuoka, 804-0093, Japan
TEL
093-871-5421
t-katou@kyoaikai.com
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Chojin |
Organization
Tobata Kyoritsu Hospital
Division name
Department of Respiratory Medicine
Zip code
8040093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu city, Fukuoka, 804-0093, Japan
TEL
093-871-5421
Homepage URL
choppy001042@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Tobata Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Tobata Kyoritsu Hospital
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
Department of Respiratory Medicine, Tobata Kyoritsu Hospital
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu city, Fukuoka, 804-0093, Japan
Tel
093-871-5421
choppy001042@yahoo.co.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
| 2015 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.kyoaikai.com/kyoritsu/aboutus/rinnsyoukenkyuu/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34419377/
Number of participants that the trial has enrolled
130
Results
The ASAP was useful for predicting short- and long-term mortalities and recurrence of pneumonia.
Results date posted
| 2023 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly patients with pneumonia (n = 130) who were admitted to Tobata Kyoritsu Hospital from January to June 2016 were enrolled prospectively.
Participant flow
Associations between their ASAP scores and in-hospital mortality, recurrence of pneumonia within 30 days, 6-month mortality, and detection of antibiotic-resistant bacteria were evaluated.
Adverse events
None
Outcome measures
in-hospital mortality, recurrence of pneumonia, and 6-month mortality. detection of antibiotic-resistant bacteria.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is cohort study. After January 2016, all patients with NHCAP in
attending hospital are enrolled.
Management information
Registered date
| 2015 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023528
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/02 | Chojin. Respiratory Investigation.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/07/02 | Chojin. Respiratory Investigation.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/07/02 | Chojin. Respiratory Investigation.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/23528
