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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002100
Receipt No. R000002544
Scientific Title The support system for elder diabetic patients with bidirectional IT communications
Date of disclosure of the study information 2009/08/01
Last modified on 2009/12/28

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Basic information
Public title The support system for elder diabetic patients with bidirectional IT communications
Acronym The support system for diabetic patients with IT
Scientific Title The support system for elder diabetic patients with bidirectional IT communications
Scientific Title:Acronym The support system for diabetic patients with IT
Region
Japan

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

Objectives
Narrative objectives1 The present study is undertaken to analyze the effects of the bidirectional IT communications on preventing diabetes from progressing and reducing a caregiver burden.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1 inspection data (height, weight,
percent of body fat, blood glucose
level, HbA1c, insulin concentration)
2 PAID (Problem Areas In Diabetes)
3 lifestyle questionnaire
4 TV telephone questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 For a period of 12 weeks, a diabetic patient and his caregiver communicate with a doctor or nurse through the TV terephone for 30 minutes once a week. Intercommunication content
:Medical staff checks a list of weight change, compliance check, exercise habit, and so on.
:checks attached pictures of the plate.
:encourages a diabetic patient to eat properly being based on the diet record.
Interventions/Control_2 Diabetic patients carry on being treated as an outpaint only and they complete the questionnaire.
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
60 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Diabetic patients are informed of the nature and purpose of the study before giving their voluntary consent to participate in the study. We select a subject who has TV terephone communication system at his home as an intervention group. Age-, duration of the diabetes-, ADL-, blood glucose-, HbA1c-, matched control group carrys on being treated as an outpaint without TV telephone communication.
Key exclusion criteria Not diabetes, Difficulty in speaking
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayae Kinoshita
Organization Kyoto University
Division name Home medical care nursing
Zip code
Address 53 Shogoin Kawahara-cho, Sakyo-ku Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization kyoto University
Division name Medical ethics committee
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku Kyoto
TEL
Homepage URL
Email

Sponsor
Institute Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2009 Year 08 Month 01 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
2009 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 22 Day
Last modified on
2009 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002544

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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