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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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