UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051478 |
|---|---|
| Receipt number | R000055762 |
| Scientific Title | Effectiveness of a Shared Decision-Making Practice Education Program Using E-learning for Mid-Career Nurses: Randomized Controlled Trial. |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2024/01/04 15:21:47 |
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Basic information
Public title
To measure the intention of mid-career nurses to practice Shared Decision-Making (SDM) in clinical practice after attending an e-learning educational program on SDM practice, and to validate the results in a randomized controlled trial.
Acronym
To measure the behavioral intentions of mid-career nurses after attending a Shared Decision-Making (SDM) practice education program.
Scientific Title
Effectiveness of a Shared Decision-Making Practice Education Program Using E-learning for Mid-Career Nurses: Randomized Controlled Trial.
Scientific Title:Acronym
Effectiveness of a Shared Decision-Making Practice Education Program for Mid-Career Nurses: Randomized Controlled Trial.
Region
| Japan |
Condition
Condition
Intention to practice SDM in clinical practice after attending an e-learning-based Shared Decision-Making (SDM) practice education program.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of an e-learning Shared Decision-Making (SDM) practice education program for mid-career nurses by measuring their intention to practice SDM in clinical settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intention to SDM in clinical practice immediately after completion of the educational program
Key secondary outcomes
(1) Perceptions of the program
(2) Factors influencing intentions
(3) Perceptions of the SDM practice environment in clinical settings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Groups that responded to a pre-questionnaire survey about their intention to practice SDM and attended one program for one month.
Interventions/Control_2
Groups that responded to the pre-questionnaire survey on SDM practice intentions but did not attend the program.
Interventions/Control_3
Groups that did not respond to the pre-questionnaire survey about their intention to practice SDM and attended one program for one month.
Interventions/Control_4
Groups that did not responded to both the pre-questionnaire survey on SDM practice intentions and the program.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 23 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) They are mid-career nurses (nurses who fall under the Clinical Ladder II or III as indicated by the Japanese Nurses Association).
2) The nurse who provides direct medical care or care to patients or their families who are the decision-makers in the workplace where she or he works.
3) The nurse is able to type, view videos, and operate Moodle using a personal computer or smartphone.
4) The nurse has access to an internet connection.
5) The nurse has access to a PC or smartphone.
6) Be at least 23 years of age at the time of obtaining the consent form.
7) Have obtained written consent from the individual to participate in this study.
Key exclusion criteria
1) Those who have learned about SDM and do not consider it necessary to learn about it.
2) Those who are deemed inappropriate by the principal investigator (or a co-researcher).
Target sample size
256
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | SEKIYAMA |
Organization
St. Luke's International University Graduate School of Nursing Science
Division name
Nursing Informatics
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
0285-58-7495
16dn008@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | SEKIYAMA |
Organization
St. Luke's International University Graduate School of Nursing Science
Division name
Nursing Informatics
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
0285-58-7495
Homepage URL
16dn008@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University Graduate School of Nursing Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University Research Ethics Review Committee
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
Tel
03-5550-2423
kenkyukikaku@luke.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
| 2023 | Year | 06 | Month | 30 | 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
2731
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055762
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/04 | 01-1.【統合指針】研究倫理審査 研究計画書2_10.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/01/04 | 仕様書2023.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/01/05 | case2023.xlsx |
