UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004535 |
|---|---|
| Receipt number | 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 16:59:22 |
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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
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
209D101@redcross.ac.jp
Sponsor or person
Institute
the Japanese red cross college of nursing
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005419
