UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050639 |
|---|---|
| Receipt number | R000057687 |
| Scientific Title | A Randomized Controlled Trial of Intervention by a Clinical Psychologist/Certified Public Psychologist in the ICU of Toyokawa City Hospital |
| Date of disclosure of the study information | 2023/03/24 |
| Last modified on | 2023/11/01 00:42:31 |
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Basic information
Public title
Effects of interviews with clinical psychologists/certified psychologists on ICU patient families
Acronym
Effects of interviews with clinical psychologists/certified psychologists on ICU patients' families
Scientific Title
A Randomized Controlled Trial of Intervention by a Clinical Psychologist/Certified Public Psychologist in the ICU of Toyokawa City Hospital
Scientific Title:Acronym
Effect of Clinical Psychologist/Certified Psychologist Intervention on ICU Patients' Families
Region
| Japan |
Condition
Condition
Post-intensive care syndrome
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At the ICU of Toyokawa City Hospital, clinical psychologists/certified psychologists conduct face-to-face interviews with patients' families as part of efforts to address the mental aspects of their families. This time, we will conduct research to investigate how this approach affects the patient's family's satisfaction and QOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Family satisfaction in the Intensive Care Unit 24 R Japanese (FS-ICU 24 R J) one month after patient discharge
Key secondary outcomes
Family QOL, anxiety/depression, and PTSD one month after patient discharge using EQ-5D, HADs, and IES-R
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group with an interview with a clinical psychologist/certified psychologist
Patients' families are attended to by ICU nurses. Then, within 72 hours after obtaining consent to participate in the study, a clinical psychologist/certified psychologist conducts one face-to-face interview. One month after the patient's discharge from the hospital, a questionnaire survey is conducted on the family.
Interventions/Control_2
A group without an interview with a clinical psychologist/certified psychologist
Patients' families are attended to by ICU nurses. However, although consent to participate in research is obtained, interviews with clinical psychologists/certified psychologists are not accepted. One month after the patient's discharge from the hospital, a questionnaire survey is conducted on the family.
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
Family members of patients admitted to the ICU who meet the following conditions:
1.Adults over the age of 18
2.Ventilator management for 48 hours or more
Key exclusion criteria
1.When consent cannot be obtained
2.If the SOFA score at the time of admission to the ICU of this hospital is 12 points or more
3.When the principal investigator deems it inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka/Yousuke/Hidenori |
| Middle name | |
| Last name | Morita/Hirata/Sumita |
Organization
Toyokawa City Hospital/Toyokawa City Hospital/Toyokawa City Hospital, Clinic Sumita
Division name
Medical Technology Bureau Medical Support Department Clinical Psychology Group/Intensive care department/Anesthesiology (part-time), Internal medicine, pediatrics
Zip code
442-8561/442-8561/442-8561,441-0105
Address
23 Noji, Yawata-cho, Toyokawa City/ 23 Noji, Yawata-cho, Toyokawa City/ 23 Noji, Yawata-cho, Toyokawa City/ Minamiyama Shinden, Ina-cho, Toyokawa City
TEL
(0533)86-1111
hideyasumusic@gmail.com
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Sumita |
Organization
Toyokawa City Hospital/Clinic Sumita
Division name
Anesthesiology (part-time) / Internal medicine, pediatrics
Zip code
442-8561/441-0105
Address
23 Noji, Yawata-cho, Toyokawa City/ 305-12 Minamiyama Shinden, Ina-cho, Toyokawa City
TEL
(0533)86-1111(0533)78-2255
Homepage URL
videhide@gmail.com
Sponsor or person
Institute
Toyokawa City Hospital PICS Team
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyokawa City Hospital Clinical Research Ethics Review Committee
Address
23 Noji, Yawata-cho, Toyokawa City
Tel
(0533)86-1111
tch@toyokawa-ch-aichi.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
豊川市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2023 | Year | 03 | Month | 21 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057687
| Research Plan | |
|---|---|
| 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 |
