UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060659 |
|---|---|
| Receipt number | R000065676 |
| Scientific Title | Development of a Nurse-Led Intervention Program to Improve the Palliative care and Quality of Dying and Death in the ICU: Evaluation of Its Feasibility, Acceptability, and Effectiveness |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/12 17:32:53 |
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Basic information
Public title
Development of a Nurse-Led Intervention Program to Improve the Palliative care and Quality of Dying and Death in the ICU: Evaluation of Its Feasibility, Acceptability, and Effectiveness
Acronym
Development of a Nurse-Led Intervention Program to Improve the Palliative care and Quality of Dying and Death in the ICU: Evaluation of Its Feasibility, Acceptability, and Effectiveness
Scientific Title
Development of a Nurse-Led Intervention Program to Improve the Palliative care and Quality of Dying and Death in the ICU: Evaluation of Its Feasibility, Acceptability, and Effectiveness
Scientific Title:Acronym
Development of a Nurse-Led Intervention Program to Improve the Quality of Dying and Death in the ICU: Evaluation of Its Feasibility, Acceptability, and Effectiveness
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Intensive care medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, acceptability, and effectiveness of a nurse-led intervention program to improve the quality of dying and death in the ICU
Basic objectives2
Others
Basic objectives -Others
feasibility, acceptability, and effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility: Compliance rates with the intervention program, Assessment of feasibility using focus group interviews with health care providers at sites implementing the intervention program
Acceptability: system usability scale
Effectiveness: Quality indicators for palliative care in the ICU
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention program to improve the quality of dying and death in the ICU
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients admitted to the ICU during the study period
Key exclusion criteria
Patients who have been offered an opt-out
Target sample size
30
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
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Kyushu International College of Nursing
Address
1-1 Asty Munakata-City, Fukuoka-Prefecture, Japan
Tel
0940-35-7001
e-ikeda@jrckicn.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
| 2026 | Year | 02 | Month | 12 | 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
| 2025 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065676
