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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004535
Receipt No. R000005419
Scientific Title An evaluation of nursing intervention in diabetic outpatients' education
Date of disclosure of the study information 2010/11/10
Last modified on 2013/05/13

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Basic information
Public title An evaluation of nursing intervention in diabetic outpatients' education
Acronym An evaluation of nursing intervention in diabetic outpatients' education
Scientific Title An evaluation of nursing intervention in diabetic outpatients' education
Scientific Title:Acronym An evaluation of nursing intervention in diabetic outpatients' education
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examine whether 15-month one-to-one lifestyle counseling by nurse for diabetic outpatients can improve their health outcomes, i.e. distress from diet, self-management for diet and exercise, HbA1c.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feelings of distress caused by diet
Self-management for diet and exercise
HbA1c
Key secondary outcomes BMI (Body Mass Index)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group receive both usual care and one-to-one counseling with a nurse (researcher) per 4-6 weeks hospital visit for 15-month. Nursing counseling besed on the Trans Theoretical Model and the Nursing Model on Education.
Interventions/Control_2 Control group receive usual care.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria HbA1c is 7.4% or over
Visit per 4-6 weeks
Key exclusion criteria Have serious ongoing illness or cognitive disorder
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Honjo Keiko
Organization the Japanese red cross college of nursing
Division name school of nursing
Zip code
Address 4-1-3 Hiroo, Shibuya-ku, Tokyo, 150-0012, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Miho Ota
Organization the Japanese red cross college of nursing
Division name graduate school of nursing, doctoral student
Zip code
Address 4-1-3 Hiroo, Shibuya-ku, Tokyo, 150-0012, Japan.
TEL
Homepage URL
Email 209D101@redcross.ac.jp

Sponsor
Institute the Japanese red cross college of nursing
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
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 たかだ内科クリニック(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
	With regard to dietary and exercise self-management (N = 88) , a significant improvement in nutritional balance was seen in the intervention group (F (1, 80) = 7.28, p < .01) versus the usual care group. Scores for amount of exercise indicated a trend towards better exercise self-management (F (1, 80) = 2.81, p = .098) in the intervention group as opposed to the usual care group. There was no significant difference between the two groups with regard to control of caloric intake or changes in meal time patterns. 
	With regard to scores on the distress scale related to diet (N = 85), there was no significant difference between the two groups. Between the two groups there was no significant difference in HbA1c (N = 85).
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
2010 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 06 Month 15 Day
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2012 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 10 Day
Last modified on
2013 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005419

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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