UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028643 |
|---|---|
| Receipt number | R000030254 |
| Scientific Title | Self-care support intervention focusing on living environments. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2018/09/18 15:47:16 |
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Basic information
Public title
Self-care support intervention focusing on living environments.
Acronym
Self-care support intervention focusing on living environments.
Scientific Title
Self-care support intervention focusing on living environments.
Scientific Title:Acronym
Self-care support intervention focusing on living environments.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of self-care support intervention focusing on living environments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of the Summary of Diabetes Self-Care Activities Measure
Key secondary outcomes
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-care support intervention suggesting what to buy or what to order based on the information of the shops or restaurants easily available for each patient.
Interventions/Control_2
conventional self-care support
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with poor control (HbA1c>=8% for more than 3 months)
Key exclusion criteria
Patients treated less than 1 year
Patients hard to answer self-reported questionnaire
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Kyoto University Hospital
Division name
Diabetes, Endocrinology and Clinical Nutrition
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3560
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Kyoto University Hospital
Division name
Diabetes, Endocrinology and Clinical Nutrition
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3560
Homepage URL
krikeda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030254
