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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035958
Receipt No. R000040954
Scientific Title Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.
Date of disclosure of the study information 2019/03/22
Last modified on 2019/02/20

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Basic information
Public title Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.
Acronym Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.
Scientific Title Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.
Scientific Title:Acronym Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.
Region
Japan

Condition
Condition 2type diabetes melitus
Classification by specialty
Endocrinology and Metabolism Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consider the effect of intervention by a care program that helps Live along with My Diabetes Mildly to those who are diagnosed with type 2 diabetes that has a period when you are not seeking treatment for diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes The assessment indicators of well beeing,selfcare ability is defined as a primary outcome and Shimizu and colleagues 2011 developed 40 elements of IDSCA,instrument of diabetes selfcare agency,developed by Orem theory based on the selfcare ability scale of diabetic patients we measure the selfcare ability with 5 elements of supportutilization power,application coordination power,the driving force of selfmanagement,the ability to selfmanage selfishly,body selfcognitive ability.
Key secondary outcomes Secondary outcome is comprehensive health-related QOL scale standard version (SF-8) (Fukuhara, Suzukamo, 2004) and symptoms of chronic complications, Consultation symptom of hyperglycemia.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Provide a care program to help prepare Live along with My Diabetes Mildly created by integrating the results of preliminary research aimed at interviews with people who have experienced discontinuation of diabetes treatment and previous studies.The care program includes seven care (care that respects the previous medical treatment method, interpretation of your diabetes myself, care to help you understand the appropriate medical regimen for yourself, care to help you acquire life skills to make your blood sugar harder to raise, Care to ease the recognition of excessive self management, care to help you to be able to borrow the power of others, care to help maintain relationships with people), in order to care gide Data are collected before intervention, twice during intervention, and one month after completion of 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
30 years-old <=
Age-upper limit
70 years-old >
Gender Male
Key inclusion criteria Having a period when the outpatient examination for the purpose of treating diabetes at the intervals required by medical institutions after diagnosis of type 2 diabetes is not performed for more than 6 months on the basis of some sort of circumstances or judgment.
Whether or not there is current work, the period during which no consultation was done does not matter.
The examination status at the time of recruitment does not matter.
Key exclusion criteria Weight loss is over 10kg in 3 months.
Difficult to communicate in Japanese, read and write in Japanese.
Difficult to walk by walking alone.
Receiving maintenance dialysis therapy.
Undergoing cancer treatment.
There is cloudiness of consciousness.
There is a ketone smell.
Blood glucose of over 500mg.
Have a serious foot ulcer.
Fever is seen.
There is painful inflammation.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoneda Akiko
Organization Yamanashi Prefectural University
Division name Nursing
Zip code
Address 1-6-1 Ikeda Kofu city Yamanashi prefecture
TEL +81-055-253-9445
Email yonedaok@yamanashi-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoneda Akiko
Organization Yamanashi Prefectural University
Division name Nursing
Zip code
Address 1-6-1 Ikeda Kofu city Yamanashi prefecture
TEL +81-055-253-9445
Homepage URL
Email yonedaok@yamanashi-ken.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization Yamanashi Prefectural University
Organization
Division
Category of Funding Organization Local Government
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
2019 Year 03 Month 22 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 21 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
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040954

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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