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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033562
Receipt No. R000038275
Scientific Title Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/30

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Basic information
Public title Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Acronym Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Scientific Title Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Scientific Title:Acronym Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Region
Japan

Condition
Condition diabetes
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to investigate the effects of foot care on self-care and related factors in diabetic patients in order to enhance support and guidance for them.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After providing foot care to diabetic patients, a questionnaire is conducted to investigate in their self-care.
Key secondary outcomes

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
Other
Interventions/Control_1 The intervention includes; 1)offering a footbath and trimming nails, 2) checking vibration perception and pressure sensation in the foot, and 3) checking whether each patient's goal of foot care is achieved. The intervention is 30 minutes long and is offered once a month for 6 months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are judged to require foot care by their doctors.
Key exclusion criteria Patients who cannot answer the questionnaire.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayami Hayashi
Organization Fukushima Medical University School of Nursing
Division name Department of Fundamental Nursing
Zip code
Address 1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan
TEL 024-547-1865
Email yami@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayami Hayashi
Organization Fukushima Medical University School of Nursing
Division name Department of Fundamental Nursing
Zip code
Address 1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan
TEL 024-547-1865
Homepage URL
Email yami@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
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
Address
Tel
Email

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
2018 Year 08 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 30 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038275

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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