UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053813 |
|---|---|
| Receipt number | R000061328 |
| Scientific Title | A study on the evaluation of communication between healthcare professionals and family members of patients in the intensive care unit, and its impact on the mental health status of the families |
| Date of disclosure of the study information | 2024/03/11 |
| Last modified on | 2024/03/09 13:50:28 |
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Basic information
Public title
A study on the evaluation of communication between healthcare professionals and family members of patients in the intensive care unit, and its impact on the mental health status of the families
Acronym
A study on the evaluation of communication between healthcare professionals and family members of patients in the intensive care unit, and its impact on the mental health status of the families
Scientific Title
A study on the evaluation of communication between healthcare professionals and family members of patients in the intensive care unit, and its impact on the mental health status of the families
Scientific Title:Acronym
A study on the evaluation of communication between healthcare professionals and family members of patients in the intensive care unit, and its impact on the mental health status of the families
Region
| Japan |
Condition
Condition
Family members of patients admitted to the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the met or unmet of family information needs in communication between family members and healthcare professionals in the ICU and the prevalence of anxiety, depression, PTSD, and PGD symptoms in family members after ICU discharge
Basic objectives2
Others
Basic objectives -Others
To investigate the association between the met or unmet of family information needs in communication between family members and healthcare professionals in the ICU and the prevalence of anxiety, depression, PTSD, and PGD symptoms in family members after ICU discharge
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the association between the evaluation of met and unmet information needs among family members of ICU patients and the prevalence of anxiety, depression, PTSD, and PGD symptoms after ICU discharge
Key secondary outcomes
The secondary outcomes are the evaluation of met and unmet information needs among family members of ICU patients and the prevalence and comorbidity of anxiety, depression, PTSD, and PGD symptoms in family members after ICU discharge
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Blood family member or partner or key person of the patient admitted to the ICU
Involved in discussions and explanations with the physician regarding medical care for the patient in the ICU
More than 1 month and less than 12 months after discharge from the ICU
Key exclusion criteria
Has physical and cognitive impairments that make it difficult to respond to questionnaires
Participating in another study
Decided by the researcher that participation is not appropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Yokobori |
Organization
Graduate School of Nippon Medical School
Division name
Departments of Emergency and Critical Care Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
shoji@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Nippon Medical School
Division name
Departments of Emergency and Critical Care Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
yoshiyasu-ito@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central Ethics Committee of the Nippon Medical School Foundation
Address
1-1-5,Sendagi,Bunkyo-ku,Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
| 2024 | Year | 03 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061328
| 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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| Registered date | File name |
