UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042681 |
|---|---|
| Receipt number | R000048694 |
| Scientific Title | Effectiveness of ICU diaries on satisfaction of family members of COVID-19 patients in the ICU |
| Date of disclosure of the study information | 2020/12/07 |
| Last modified on | 2022/06/09 09:25:35 |
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Basic information
Public title
Effectiveness of ICU diaries on satisfaction of family members of COVID-19 patients in the ICU
Acronym
Effectiveness of ICU diaries on satisfaction of family members of COVID-19 patients in the ICU
Scientific Title
Effectiveness of ICU diaries on satisfaction of family members of COVID-19 patients in the ICU
Scientific Title:Acronym
Effectiveness of ICU diaries on satisfaction of family members of COVID-19 patients in the ICU
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the changes in family satisfaction before and after receiving the ICU diary.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction of family members of COVID-19 patients
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Family members of COVID-19 patients in the ICU
Key exclusion criteria
Family members who refused to be interviewed
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | JUNPEI |
| Middle name | |
| Last name | HARUNA |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
064-0821
Address
BRANZ MARUYAMA503
TEL
09062141114
jp.haruna@hotmail.co.jp
Public contact
Name of contact person
| 1st name | JUNPEI |
| Middle name | |
| Last name | HARUNA |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
060-8543
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL
09062141114
Homepage URL
jp.haruna@hotmail.co.jp
Sponsor or person
Institute
Department of Intensive Care Medicine, Sapporo Medical University, School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
Tel
0116112111
jp.haruna@hotmail.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
| 2020 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
4
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048694
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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