UMIN-CTR Clinical Trial

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
Email	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
Email	keisukeh@sapmed.ac.jp

Sponsor
Institute	Emergency medicine, Sapporo Medical University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046658