UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029299 |
|---|---|
| Receipt number | R000033486 |
| Scientific Title | Research on development of self-monitoring function promotion nursing care program for patients with high risk for diabetic foot |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2021/03/31 10:41:10 |
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Basic information
Public title
Research on development of self-monitoring function promotion nursing care program for patients with high risk for diabetic foot
Acronym
Development of self-monitoring function promotion nursing care program for high risk patients with diabetic foot
Scientific Title
Research on development of self-monitoring function promotion nursing care program for patients with high risk for diabetic foot
Scientific Title:Acronym
Development of self-monitoring function promotion nursing care program for high risk patients with diabetic foot
Region
| Japan |
Condition
Condition
diabetic foot
Classification by specialty
| Endocrinology and Metabolism | Dermatology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a nursing care program to promote the self monitoring function of high-risk patients with diabetic foot and to confirm the effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in self-monitoring function on patient's foot care at outpatient visits(awareness,recordings,interpretations)
Key secondary outcomes
General Self-Efficacy Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The nurse uses care of "my foot care record" when the patient visits footcare outpatient
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patient is a diabetic patient who is visiting a foot care outpatient
2.Patient can communicate in Japanese
3.Patient knows diabetic foot
4.Patient can observe his or her feet by himself and has a physical function capable of performing foot care or their family can support them
5.Patient doesn't have serious cognitive disorder and mental disease
Key exclusion criteria
The primary doctor judged that patient can not participate in the questionnaire survey / program for physical, mental and cognitive reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Uchibori |
Organization
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name
Home Care Nursing
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5356
uchibori.chn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Uchibori |
Organization
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name
Home Care Nursing
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5356
Homepage URL
uchibori.chn@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5356
uchibori.chn@tmd.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
| 2017 | Year | 10 | Month | 24 | 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
18
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
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 09 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033486
