UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040869 |
|---|---|
| Receipt number | R000046658 |
| Scientific Title | A prospective cohort observational study to clarify the incidence of post-intensive care syndrome and the impact of information provision in families of patients with out-of-hospital cardiac arrest |
| Date of disclosure of the study information | 2020/08/13 |
| Last modified on | 2022/08/26 21:16:28 |
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Basic information
Public title
A prospective cohort observational study to clarify the incidence of post-intensive care syndrome and the impact of information provision in families of patients with out-of-hospital cardiac arrest
Acronym
A prospective cohort observational study to clarify the incidence of post-intensive care syndrome and the impact of information provision in families of patients with out-of-hospital cardiac arrest
Scientific Title
A prospective cohort observational study to clarify the incidence of post-intensive care syndrome and the impact of information provision in families of patients with out-of-hospital cardiac arrest
Scientific Title:Acronym
A prospective cohort observational study to clarify the incidence of post-intensive care syndrome and the impact of information provision in families of patients with out-of-hospital cardiac arrest
Region
| Japan |
Condition
Condition
family's post-intensive care syndrome
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine if the information provided in the brochure reduces family PICS-F.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Impact of Event Scale-Revised:IES-R
Key secondary outcomes
Hospital Anxiety and Depression Scale:HADS
EQ-5D-5L
Brochure comprehension, family physical characteristics/social status/history of mental illness, patient physical characteristics/social status/treatment progress information
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Non-intervention group: No pamphlet intervention
Interventions/Control_2
Medical explanation group:Providing information through pamphlets that help families understand the patient's situation and accept the current situation
Interventions/Control_3
Medical/social explanation group:In addition to the control group pamphlet, we will provide information by pamphlet containing information on social resources and economic support
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Family members over 20 years old of patients over 20 years old admitted for out-of-hospital cardiac arrestA family of patients who have been carried in a cardiac arrest due to cardiovascular disease or a cardiac arrest due to cerebrovascular diseaseFamily members who can obtain consent from their families to participate in the studyFamily who can answer questionnaire using Google form
Key exclusion criteria
If the patient died before obtaining the consent document
When the disease caused by hospitalization is hospitalization due to re-hospitalization such as recurrence
In addition, when the doctor in charge judges that the registration of this study is inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Harada |
Organization
Sapporo Medical University Hospital
Division name
Emergency medicine
Zip code
060-8543
Address
16-291 South 16 West 1 Chuo-ku, Sapporo-shi, Hokkaido
TEL
011-611-2111
keisukeh@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Harada |
Organization
Sapporo Medical University Hospital
Division name
Emergency medicine
Zip code
060-8543
Address
16-291 South 16 West 1 Chuo-ku, Sapporo-shi, Hokkaido
TEL
011-611-2111
Homepage URL
keisukeh@sapmed.ac.jp
Sponsor or person
Institute
Emergency medicine, Sapporo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
16-291 South 16 West 1 Chuo-ku, Sapporo-shi
Tel
011-611-2111
keisukeh@sapmed.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 | 08 | Month | 13 | 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
0
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
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
