UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053307 |
|---|---|
| Receipt number | R000060847 |
| Scientific Title | Multicenter prospective observational study on post-traumatic stress disorder due to experiencing a family member's cardiac arrest and its care |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/10 12:14:56 |
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Basic information
Public title
A Study on post-traumatic stress disorder due to experiencing a family member's cardiac arrest and its care
Acronym
Study on family's death related PTSD
Scientific Title
Multicenter prospective observational study on post-traumatic stress disorder due to experiencing a family member's cardiac arrest and its care
Scientific Title:Acronym
Prospective observational study on family's death related PTSD
Region
| Japan |
Condition
Condition
Post traumatic stress disorder
Classification by specialty
| Psychosomatic Internal Medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to investigate the psychological impact of out-of-hospital cardiac arrest events on patient families in Japan through a multicenter prospective collaborative study and identify the frequency of PTSD occurrence and its risk factors based on established disease concepts. The goal is to gain an understanding of the current state of the psychological impact of out-of-hospital cardiac arrest on patient families in Japan and obtain foundational data for considering effective mental care for patient families.
Basic objectives2
Others
Basic objectives -Others
Not applicable.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The occurrence of post-traumatic stress disorder in family members of patients 90 days after experiencing cardiac arrest.
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
| 20 | years-old | <= |
Age-upper limit
| 150 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study includes family members (aged 20 and above) of patients transported to participating facilities as out-of-hospital cardiac arrests. Family members are defined as the spouse, parents, children, and siblings of the cardiac arrest patients, and in cases where multiple relationships apply, the research prioritizes them in the mentioned order
Key exclusion criteria
In cases where research participation consent cannot be obtained.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Shibahashi |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Tertiary Emergency Medical Center
Zip code
130-0022
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo 130-8575, Japan
TEL
03-3633-6151
kshibahashi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Shibahashi |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Tertiary Emergency Medical Center
Zip code
130-0022
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo 130-8575, Japan
TEL
03-3633-6151
Homepage URL
kshibahashi@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Acute Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
institutional review board of Metropolitan
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo 130-8575, Japan
Tel
03-3633-6151
chiaki_miyamoto@tmhp.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
| 2024 | Year | 01 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct follow-up surveys via telephone with research participants 90 days after the occurrence of the cardiac arrest event. The Impact of Event Scale-Revised (Japanese version) (IES-r) and the Hospital Anxiety and Depression Scale (Japanese version) will be utilized to assess the psychological status. An IES-r score >30 will be defined as post-traumatic stress disorder (PTSD), and the frequency of its occurrence and risk factors will be investigated. For the purpose of identifying risk factors, information will be collected for each case on patient factors (age, gender, history of chronic illnesses, daily activities before cardiac arrest, patient family factors, marital status), information about the cardiac arrest (witnessing, cardiopulmonary resuscitation performed by family members who witnessed the event, cause of cardiac arrest [trauma, suicide, other]), initial electrocardiogram waveform, and care received at the hospital.
Through the aforementioned survey, quantitative information on anxiety and depression experienced by those who have undergone a family member's cardiac arrest will first be obtained, and the frequency of PTSD will be elucidated. Subsequently, univariate analysis will extract factors related to the occurrence of PTSD 90 days after the event. Using the occurrence of PTSD as the dependent variable and the related factors identified through univariate analysis as independent variables, a multiple logistic regression model (significance level, 0.05) will be employed to identify independent risk factors.
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060847
