UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052289 |
|---|---|
| Receipt number | R000059692 |
| Scientific Title | Investigating the effectiveness of an educational program to prevent the development of foot lesions in elderly diabetic patients. |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2023/09/23 15:37:30 |
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Basic information
Public title
Investigating the effectiveness of an educational program to prevent the development of foot lesions in elderly diabetic patients.
Acronym
Investigating the effectiveness of an educational program to prevent the development of foot lesions in elderly diabetic patients.
Scientific Title
Investigating the effectiveness of an educational program to prevent the development of foot lesions in elderly diabetic patients.
Scientific Title:Acronym
Investigating the effectiveness of an educational program to prevent the development of foot lesions in elderly diabetic patients.
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the effectiveness of an educational program, (SFCODP), which is expected to prevent the development of foot lesions in elderly diabetic patients.
Basic objectives2
Others
Basic objectives -Others
This study will evaluate the effectiveness of an educational program, (SFCODP), which is expected to prevent the development of foot lesions in elderly diabetic patients.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Foot lesion occurrence
Key secondary outcomes
Self-efficacy, self-care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Framework-based intervention program using nudges
Interventions/Control_2
Nomal FootCare
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
| 65 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Able to make outpatient visits on their own
Key exclusion criteria
Cognitive decline, those whose attending physician has determined that they are not eligible to participate in the study.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Sable-Morita |
Organization
NCGG
Division name
Nursing
Zip code
4748511
Address
430-7,obushi,moriokacyo,Aichi
TEL
0562462311
mme.sayu@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Sable-Morita |
Organization
NCGG
Division name
Nursing
Zip code
4748511
Address
430-7,obushi,moriokacyo,Aichi
TEL
0562462311
Homepage URL
mme.sayu@ncgg.go.jp
Sponsor or person
Institute
NCGG
Institute
Department
Personal name
Sayuri Sable-Morita
Funding Source
Organization
NCGG
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCGG
Address
430-7,obushi,moriokacyo,Aichi
Tel
0562462311
mme.sayu@ncgg.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
22030
Org. issuing International ID_1
Nagoya City Univercity
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立長寿医療研究センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 25 | 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
130
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
no
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 23 | Day |
Last modified on
| 2023 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059692
