UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044735 |
|---|---|
| Receipt number | R000050946 |
| Scientific Title | Development and Evaluation of the Education Program for Visiting Nurses in Foot-Care of Diabetes Patients |
| Date of disclosure of the study information | 2021/07/02 |
| Last modified on | 2023/01/02 15:56:27 |
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Basic information
Public title
Development and Evaluation of the Education Program for Visiting Nurses in Foot-Care of Diabetes Patients
Acronym
Development and Evaluation of the Education Program for Visiting Nurses in Foot-Care of Diabetes Patients
Scientific Title
Development and Evaluation of the Education Program for Visiting Nurses in Foot-Care of Diabetes Patients
Scientific Title:Acronym
Development and Evaluation of the Education Program for Visiting Nurses in Foot-Care of Diabetes Patients
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and evaluate the educational program for visiting nurses who provide foot-care to diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcomes are the differences between the means of the knowledge test scores of the two groups one month after the educational intervention was given to the intervention group (T2) using the Foot Care Knowledge Test of Fill-in-the-Blank and Case Selection Questions (25 point scale).
Key secondary outcomes
1)Secondary Outcomes are the differences in the scores on the Foot Care Skills Test (5-point scale)and the Foot Care Attitude Test (5-point scale), the differences in the total scores on the Foot Care Knowledge and Skills Test (30-point scale), and the differences in the total scores on the Foot Care Knowledge, Skills, and Attitude Test (35-point scale) between the two groups one month after the end of the intervention (T2), as well as before the intervention (T0), immediately after the intervention (T1).
2)Secondary Outcomes are evaluated by conducting individual content analysis of the intervention group regarding their awareness and impressions of the "content" and "method" of the educational program and the development of an action plan for foot care for multidisciplinary cooperation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The educational program was developed as an e-learning material consisting of five lectures (165 minutes) on the pathogenesis and treatment of diabetic foot lesions and foot assessment, and four exercises (70 minutes) on foot observation and nail filing.
The intervention group will be provided with the developed educational program and will be tested on their foot care knowledge, skill and attitude.
Interventions/Control_2
The control group will not be provided with the developed educational program, but only with the foot care knowledge, skills, and attitude test.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those with at least five years of experience as a nurse and at least one year of experience as a visiting nurse.
2) Those who have not participated in the training program to acquire knowledge and skills of foot care for diabetic patients as a nurse.
3) Those who are able to attend all the educational programs (5 lectures and 4 exercises) and take the knowledge, skill and attitude tests.
4) Those who can attend the educational programs by e-learning at the facility they belong to or at a location of their choice, and who can prepare the Internet environment to take the knowledge and skill tests using a cell phone or tablet equipped with a camera.
Key exclusion criteria
Those who have no experience in providing foot care education to diabetic patients and their families.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Sone |
Organization
St. Luke's International University Graduate School
Division name
Doctoral course in Adult Nursing, Chronic Care Nursing
Zip code
104-004
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
16DN009@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Masasko |
| Middle name | |
| Last name | Sone |
Organization
St. Luke's International University Graduate School
Division name
Doctoral course in Adult Nursing, Chronic Care Nursing
Zip code
104-004
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
Homepage URL
16DN009@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University Graduate School
Doctoral course in Adult Nursing, Chronic Care Nursing
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
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 Graduate School
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-3543-6391
16DN009@slcn.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 | 07 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | 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
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050946
