UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052479 |
|---|---|
| Receipt number | R000058959 |
| Scientific Title | Translation, validity of the Japanese version of Quality of Dying and Death questionnaire for family member in the ICU |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2024/04/11 19:55:22 |
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Basic information
Public title
Development of the Quality of Dying and Death questionnaire for family member Japanese version in the ICU
Acronym
Development of the Quality of Dying and Death questionnaire for family member Japanese version in the ICU
Scientific Title
Translation, validity of the Japanese version of Quality of Dying and Death questionnaire for family member in the ICU
Scientific Title:Acronym
Translation, validity of the Japanese version of Quality of Dying and Death questionnaire
Region
| Japan |
Condition
Condition
Families of patients in ICU
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to create a scientifically valid Japanese version of the ICU-QODD Questionnaire for Family Membe through translation.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the ICU-QODD Questionnaire for Family Member
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Expert panel
1. Certified nurses or certified nurse specialists in the areas of intensive care, emergency, and oncology
2. Educators/Researchers specializing in critical care nursing
3. Physicians involved in intensive care or end-of-life care
4. Clinical psychologists
5. Anyone (including healthcare professionals) who has experienced the loss of a family member in the ICU
Pilot Test
1. Family members of a patient admitted to the ICU
2. Family members who visit the patient during their stay in the ICU
3. Family members over 18 years old
Key exclusion criteria
Expert panel
1. Those who can't give consent to participate in the study
2. Individuals who have no experience in end-of-life care
3. Individuals who have a conflict of interest with the research
4. Non-native speakers of Japanese
Pilot Test
1. Those who can't give consent to participate in the study
2. Family members of patients with a poor prognosis
3. Non-native speakers of Japanese
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Naya |
Organization
Tokyo Healthcare University
Division name
Wakayama Faculty of Nursing
Zip code
640-8538
Address
3 Higashisakanouecho, Wakayama City, Wakayama
TEL
073-435-5819
k-naya@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Naya |
Organization
Tokyo Healthcare University
Division name
Wakayama Faculty of Nursing
Zip code
640-8538
Address
3 Higashisakanouecho, Wakayama City, Wakayama
TEL
073-435-5819
Homepage URL
k-naya@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Kazuaki Naya
Funding Source
Organization
N/A
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
Ethics committee of Japanese Red Cross Wakayama Medical Center
Address
4-20 Komatsubara-dori, Wakayama City, Wakayama
Tel
073-422-4171
N/A
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
| 2023 | Year | 10 | Month | 15 | 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
A pilot test and Expert panel using the Japanese version of the Quality of Dying and Death questionnaire was conducted to evaluate item clarity.
Content validity was verified by experts. As a result, validity was confirmed.
Results date posted
| 2024 | Year | 04 | Month | 11 | Day |
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 | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cross-sectional study
Subjects who meet the eligibility criteria will be selected from electronic medical records. The study will be explained over the telephone, and questionnaires will be mailed to those who have granted permission to receive them by mail.
Management information
Registered date
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058959
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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