UMIN-CTR Clinical Trial

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
Email	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
Email	16dn009@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040397