UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005925 |
|---|---|
| Receipt number | R000007007 |
| Scientific Title | Effects of telenursing intervention for diabetic patients. |
| Date of disclosure of the study information | 2011/07/05 |
| Last modified on | 2012/08/09 11:23:09 |
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Basic information
Public title
Effects of telenursing intervention for diabetic patients.
Acronym
An evaluation of The Telenursing System for chronic patients.
Scientific Title
Effects of telenursing intervention for diabetic patients.
Scientific Title:Acronym
An evaluation of The Telenursing System for chronic patients.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study are to clarify the evaluation and improvement of clinical application of The Telenursing System and to investigate the effectiveness of diabetic patients' self-management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation and improvement of clinical application of The Telenursing System/Goal Attainment Scaling(GAS)/Stage of Change Model/ Self-efficacy/PAID/changes in motivation to self-management/HbA1c/BMI
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Diabetic patients receive the intervention twice a week. The period is 2-6 months, depending on the patient.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Type 2 diabetes outpatient with experience of hospitalization.
2.Do not take insulin.
3.Within six months of starting the diabetes self-management.
4.Have the ability to send e-mail and web browsing.
Key exclusion criteria
1.With severe chronic complications of diabetes.
2.With cognitive impairment and mental disorders.
3.Pregnant.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayasu Kawaguchi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL
029-853-8193
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Higano |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
TEL
Homepage URL
khigano@md.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 05 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 05 | Day |
Last modified on
| 2012 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007007
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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