UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048105 |
|---|---|
| Receipt number | R000054825 |
| Scientific Title | A follow-up study after implementation of an educational program for nurses to observe and assess the oral cavity of diabetic outpatients. |
| Date of disclosure of the study information | 2022/09/17 |
| Last modified on | 2022/06/20 09:53:44 |
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Basic information
Public title
A follow-up study after implementation of an educational program for nurses to observe and assess the oral cavity of diabetic outpatients.
Acronym
A follow-up study of a nurse education program in diabetic oral management
Scientific Title
A follow-up study after implementation of an educational program for nurses to observe and assess the oral cavity of diabetic outpatients.
Scientific Title:Acronym
A follow-up study of a nurse education program in diabetic oral management
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to follow the participants of the educational program, which was conducted in the form of a training session, to inquire about their satisfaction with the educational program, and at the same time, to clarify through interviews how the knowledge and skills acquired in the educational program are used in clinical practice and the factors that influence the actual utilization as the effects of the educational program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Practical outcomes after the educational program: actual utilization of the learning in the educational program in clinical settings, and factors and reasons that influence the actual utilization.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet the following criteria
(1) Attend an exchange meeting held by the researcher at an academic meeting attended by many of the educational subjects of the educational program of this study
(2) Engaged in nursing care for diabetic patients in an outpatient setting at the time the study begins
Key exclusion criteria
Persons who meet any of the following conditions
(1) Unable to cooperate in an interview survey that takes about one hour
(2) Unable to give consent to cooperate in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Shibayama |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
0298533433
taiga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Shibayama |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
0298533433
Homepage URL
taiga@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical IRB, Faculty of Medicine, University of Tsukuba
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
Tel
0298533022
sien.ningenss@un.tsukuba.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
| 2022 | Year | 09 | Month | 17 | 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
| 2022 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected through structured interviews using a face sheet and checklist for subject background, and semi-structured interviews using a pre-prepared interview guide for practice outcomes after the educational program. In order to efficiently approach nurses engaged in diabetes nursing in outpatient settings, who are the educational targets of this study's educational program, the researchers will hold an exchange meeting about the educational program during the 27th Annual Meeting of the Japanese Society of Diabetes Education and Nursing and will recruit subjects from among the participants of that meeting. The researchers will verbally explain the outline of the study to nurses who are currently engaged in nursing care for diabetic patients in an outpatient setting using an explanatory document and a consent form, and request their cooperation in the study.
Nurses whose consent is confirmed in writing will be interviewed approximately 2 to 3 months after the educational program. The subject will be contacted at the contact information provided on the consent form to arrange a date, time, and location where interviews can be conducted. The location of the interview will be determined by the research collaborator's preference. If an interview location cannot be secured, the interview will be conducted in Room 217 or Room 412 of Building 4B at the University of Tsukuba, but in such cases, the subject will be informed in advance in writing that he/she will be responsible for transportation expenses to come to the university.
Before starting the interview, we will ask the participants to fill out a face sheet and a checklist. The interview will last from 30 minutes to one hour and will be conducted after the researcher obtains verbal consent in writing before the interview begins. The researcher will also explain that recording and note-taking during the interview will be included in the consent.
Management information
Registered date
| 2022 | Year | 06 | Month | 20 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054825
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/21 | 資料8 研究計画書 ver.2 k.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/06/21 | 資料7 インタビューガイド.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/06/21 | インタビュー_渡辺氏.docx |
