UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035467 |
|---|---|
| Receipt number | R000040397 |
| Scientific Title | Evaluation of Care Program for Home-visiting Nurses Regarding Foot Care Self-management for Type 2 Diabetic Patients: A Pilot Study |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/09/10 23:49:07 |
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Basic information
Public title
Evaluation of Care Program for Home-visiting Nurses Regarding Foot Care Self-management for Type 2 Diabetic Patients: A Pilot Study
Acronym
Evaluation of Care Program for Home-visiting Nurses Regarding Foot Care Self-management for Type 2 Diabetic Patients: A Pilot Study
Scientific Title
Evaluation of Care Program for Home-visiting Nurses Regarding Foot Care Self-management for Type 2 Diabetic Patients: A Pilot Study
Scientific Title:Acronym
Evaluation of Care Program for Home-visiting Nurses Regarding Foot Care Self-management for Type 2 Diabetic Patients: A Pilot Study
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 evaluate the care program for home- visiting nurses supporting the self-management in the foot care of the diabetic patients of the investigation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of diabetic foot ulceration(before the intervention, immediately after the intervention,after 1 week and after 2 weeks and after 3 weeks and after 4 weeks of the intervention)
Key secondary outcomes
1)Foot care self-management of diabetic patients(before the intervention, immediately after the intervention,(before the intervention, immediately after the intervention,after 1 week and after 2 weeks and after 3 weeks and after 4 weeks of the intervention)
2)Non-ulcerated foot condition(skin external color, skin drying, wound, blister, edema, callus, corn, shoe sore bean, tinea pedis, tinea unguium, feeling of cold, numbness, foot transformation) of diabetic patients(before the intervention, immediately after the intervention,after 1 week and after 2 weeks and after 3 weeks and after 4 weeks of the intervention)
3)Understanding of the knowledge, the acquirement of the technique, satisfaction of the available educational program , future utilization, impression of home-visiting nurses (after attending two days in the care programe )
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
After home- visiting nurses attends the care program of 2 days, they carry out foot care (method of the choice of an idea, shoes and socks of the everyday life to protect ,observation of the foot, the foot bath, nail care of the foot) to a diabetic patient and evaluate the incidence of diabetic foot ulceration, the foot care self-management, a nondiabetic foot ulcer condition in approximately intervention.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Home-visiting nurse who has the experience of the nurse more than five years
2) Home-visiting nurse who has the experience of the visiting nurse more than one year
3)Home-visiting nurse who has experience of the foot care that cooperated with nurse outpatient more than one year
4)Home-visiting nurse who is available for the attendance of the educational program proposal of 2 days
5)Diabetic patient who receives foot care from a home-visiting nurse
Key exclusion criteria
1)Home-visiting nurse who does not work by clinical practice
2)Diabetic patient who does not receive foot care from a home-visiting nurse
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Sone |
Organization
St. Luke's International University
Division name
Graduate School Doctoral course in Adult Nursing
Zip code
104-004
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
16dn009@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Sone |
Organization
St. Luke's International University
Division name
Graduate School Doctoral course in Adult Nursing
Zip code
104-004
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
Homepage URL
16dn009@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
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
| 2019 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040397
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