UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045769 |
|---|---|
| Receipt number | R000052252 |
| Scientific Title | Development of a Nurses' Care Coordination Competency Self Assessment Application for Patients on Life Support System in Intensive Care Units. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/04/27 15:14:31 |
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Basic information
Public title
Development of a Nurses' Care Coordination Competency Self Assessment Application for Patients on Life Support System in Intensive Care Units.
Acronym
Development of a Nurses' Care Coordination Competency Self Assessment Application for Patients on Life Support System in Intensive Care Units.
Scientific Title
Development of a Nurses' Care Coordination Competency Self Assessment Application for Patients on Life Support System in Intensive Care Units.
Scientific Title:Acronym
Development of a Nurses' Care Coordination Competency Self Assessment Application for Patients on Life Support System in Intensive Care Units.
Region
| Japan |
Condition
Condition
Nurse
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an application for self assessing Nurses' Care Coordination Competency for Patients on Life Support System in Intensive Care Unit and to verify its educational effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase in Nurses' Care Coordination Competency Scale scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
1. Measurement of care coordination competency scale score of intensive care unit nurses for patients on life support system.
2. Feedback on the results of the analysis of the scale score
3. One month later, Measure again the Care Coordination Competency Scale score of intensive care unit nurses for patients on life support system.
Interventions/Control_2
1. Measurement of care coordination competency scale score of intensive care unit nurses for patients on life support system.
2. One month later, Measure again the Care Coordination Competency Scale score of intensive care unit nurses for patients on life support system.
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
Nurses who work in intensive care units and routinely care for patients on life support system such as ventilators and assisted circulation.
Key exclusion criteria
None
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Takiguchi |
Organization
Toho University
Division name
Faculty of Health Sciences
Zip code
274-8510
Address
Miyama 2-2-1, Funabashi, Chiba
TEL
047-472-2065
chie.takiguchi@hs.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Takiguchi |
Organization
Toho University
Division name
Faculty of Health Sciences
Zip code
274-8510
Address
Miyama 2-2-1, Funabashi, Chiba
TEL
047-472-2065
Homepage URL
chie.takiguchi@hs.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
TERUMO LIFE SCIENCE FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University
Address
Miyama 2-2-1, Funabashi,Chiba
Tel
047-472-2065
chie.takiguchi@hs.toho-u.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
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jjns.12584
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/jjns.12584
Number of participants that the trial has enrolled
318
Results
Forty-one participants were lost to follow-up, leaving 277 participants (intervention = 141, control = 136) for analysis. One month later, NCCCS scores similarly increased in both groups. For nurses with at least 5 years of ICU experience (n = 152), the NCCCS score increased in the intervention group (n = 75) (rising point mean: 4.8, standard deviation [SD]: 9.8) compared with that in the control group (n = 77) (rising point mean: 1.3, SD: 8.3) (p = .048).
Results date posted
| 2024 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 318 ICU nurses from acute hospitals in Japan.
Participant flow
Forty-one participants were lost to follow-up, leaving 277 participants (intervention = 141, control = 136) for analysis.
Adverse events
None.
Outcome measures
The primary outcome was an increase in the NCCCS score 1 month after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052252
