UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053822
Receipt number R000061428
Scientific Title Validity and reliability validation of the "Intensive Care Unit Version for Quality of Dying and Death for Family members in Japanese".
Date of disclosure of the study information 2024/03/15
Last modified on 2024/03/11 09:37:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Validity and reliability validation of the "Intensive Care Unit Version for Quality of Dying and Death for Family members in Japanese".

Acronym

Validity and reliability validation of the "ICU-QODD in Japanese"

Scientific Title

Validity and reliability validation of the "Intensive Care Unit Version for Quality of Dying and Death for Family members in Japanese".

Scientific Title:Acronym

Validity and reliability validation of the "ICU-QODD in Japanese"

Region

Japan


Condition

Condition

Family members of patient who died in ICU

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the reliability and validity of the Japanese version of the Quality of Dying and Death Questionnaire for Family Members (ICU-QODD).

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Retrospective survey for bereaved family members (within 6 months to 5 years after bereavement): Scores of ICU-QODD Japanese version
Prospective survey for bereaved family members: Scores of ICU-QODD Japanese version
Prospective survey for nurses: Scores of ICU-QODD Japanese version (for nurses)

Key secondary outcomes

Prospective survey for bereaved family members: Scores of FS-ICU Japanese version


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

Retrospective survey for bereaved family members
a. Families of patients who had an emergency admission to the ICU and stayed for more than 48 hours in the past 6 months to 5 years at the time of the survey; b. family members of patients who were diagnosed as life-threatening in the ICU and died in the ICU or HCU; c. persons over 18 years of age

Prospective survey for bereaved family members
a. Family members of patient who had an emergency admission to the ICU or HCU and stayed for more than 48 hours since the start of the study; b. family members of patients who were diagnosed as life-threatening in the ICU and died in the ICU or HCU; c. persons over 18 years of age; d. more than 3 months have passed since the patient's bereavement

Prospective survey for nurses
a. ICU nurses; b. since the beginning of the study, "patients who stayed in the ICU or HCU for more than 48 hours after emergency admission and who died in the ICU or HCU" in the last duty cycle

Key exclusion criteria

Retrospective survey for bereaved family members
a. Consent cannot be obtained; b. Family members of patient who has been in the ICU or HCU for less than 48 hours; c. Family members who have not visited the patient during his/her stay in the ICU; d. Medical record data indicate a high psychological burden due to participation in the study; e. Have a mental illness; f. Non-native Japanese speaker

Prospective survey for bereaved family members
a. Consent cannot be obtained; b. Family members of patient who has been in the ICU or HCU for less than 48 hours; c. Family members who have not visited the patient during his/her stay in the ICU; d. Medical record data indicate a high psychological burden due to participation in the study; e. Have a mental illness; f. Non-native Japanese speaker; g. The researcher determined at the time of the survey request that the subject was inappropriate for the survey

Prospective survey for nurses
a. Consent cannot be obtained; b. Not in charge of a patient who has died in the ICU or HCU since the start of the study; c. Team member of this study

Target sample size

46


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

Email

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


Email

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

Email

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

2024 Year 03 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


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

2023 Year 08 Month 09 Day

Date of IRB

2023 Year 10 Month 10 Day

Anticipated trial start date

2024 Year 04 Month 01 Day

Last follow-up date

2024 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

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

2024 Year 03 Month 11 Day

Last modified on

2024 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061428


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name