UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062168 |
|---|---|
| Receipt number | R000071109 |
| Scientific Title | The Effectiveness of an Educational Program on Care Competency: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/07 16:16:15 |
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Basic information
Public title
The Effectiveness of an Educational Program on Care Competency for the General Public: A Randomized Controlled Trial
Acronym
ECC-Study
Scientific Title
The Effectiveness of an Educational Program on Care Competency: A Randomized Controlled Trial
Scientific Title:Acronym
ECC-Study
Region
| Japan |
Condition
Condition
general public
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of the "Learning Together Care Course," which was developed to improve the care competency of the general public. Specifically, a randomized controlled trial (RCT) will be conducted to scientifically clarify the impact of participating in this course on citizens' care competency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Care Competency Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study evaluates the effectiveness of the "Learning Together Care Course" designed to improve care competency.
[Intervention Group (Course Participants)]
1. Course Attendance: Total of 12 sessions over 6 days (2 lectures per day, 80 minutes per lecture). It will be conducted face-to-face at the Global Nursing Research Center (GNRC) Open Lab, The University of Tokyo. Optionally, participants can stay at the venue for 1 hour after each session for interaction and reflection.
2. Assessment Schedule: A baseline assessment (T0) before the course, a post-assessment (T1) immediately after the final session, and a 3-month follow-up assessment (T2) will be conducted.
3. Incentive: Participants who complete all three assessments (T0, T1, T2) will receive a monetary-equivalent reward (worth 1,000 JPY) by mail.
Interventions/Control_2
[Control Group (Waitlist Control)]
1. Usual Lifestyle & Assessment: Participants will maintain their usual lifestyle without any specific intervention during the course period. They will receive a post-assessment (T1) via email at the same time as the intervention group (approx. 3-4 months from baseline), followed by a 3-month follow-up assessment (T2).
2. On-demand Access: After completing the T2 assessment, participants will receive email access to the recorded lectures for on-demand viewing.
3. Additional Assessment: A 6-month follow-up assessment (T3) will be conducted via email (6 months after the intervention group's final session).
4. Incentive: Participants who complete three or more assessments will receive a monetary-equivalent reward (worth 1,000 JPY) by mail.
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
Participants who meet the following criteria will be included in the study:
1. Residents, commuters, or students in Bunkyo-ku, aged 18 years or older.
2. Individuals who are able to continuously participate in the program throughout the study period.
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from the study:
1. Individuals who refuse or opt out of having their data used for this study.
2. Individuals who are unable to attend all scheduled sessions at the time of application to the program.
3. Individuals who have difficulty participating in the program or completing the questionnaires in Japanese.
4. Individuals deemed unsuitable for participation by the researchers (e.g., those with a suspected significant decline in cognitive function, or those suspected of posing a danger to other participants during group activities).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Yamamoto-Mitani |
Organization
The University of Tokyo
Division name
Global Nursing Research Center
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3690
cc-group@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Noguchi-Watanabe |
Organization
The University of Tokyo
Division name
Global Nursing Research Center
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3690
Homepage URL
cc-group@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Bunkyo-ku
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
shishin-ohrs@m.u-tokyo.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 | 07 | Month | 10 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 16 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071109
