UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020062 |
|---|---|
| Receipt number | R000023172 |
| Scientific Title | Development of the self-efficacy questionnaire for insulin users (Study) |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2017/06/05 08:41:59 |
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Basic information
Public title
Development of the self-efficacy questionnaire for insulin users (Study)
Acronym
Development of the self-efficacy questionnaire for insulin users (Study) [THE SELF-EFFICACY-Q Study]
Scientific Title
Development of the self-efficacy questionnaire for insulin users (Study)
Scientific Title:Acronym
Development of the self-efficacy questionnaire for insulin users (Study) [THE SELF-EFFICACY-Q Study]
Region
| Japan |
Condition
Condition
Type 1 and Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compose a questionnaire to measure self-efficacy of Japanese diabetic patients who use insulin and adjust the dosage by themselves.
Basic objectives2
Others
Basic objectives -Others
Making a new questionnaire and evaluating it
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Evaluation of the new self-efficacy questionnaire (validity and reliability)
* Evaluation of correlations between the new self-efficacy questionnaire and other questionnaires (DTSQ, PAID)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included in this study.
1. Out-patients who has been on insulin treatment for 12 weeks or longer (either type 1 or type 2 diabetes)
2. Male or female who is 20 years of age or older at the point of giving written consent
3. Patients who can provided written consent to participate in the study
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study.
1. Currently have psychological disorders, dementia, or dementia-like symptoms
2. Incapable of making judgement for themselves
3. Need a proxy to make any important judgement for them
4. Other conditions considered to be unsuitable by the attending physician
Target sample size
236
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ishii |
Organization
Nara Medical University
Division name
Department of Diabetology
Zip code
Address
840 Shinjouchou, Kashihara-shi, Nara
TEL
0744-22-3051
hits1@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
Address
NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Japan Society for Patient Reported Outcome (PRO)
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 12 | Month | 03 | 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
| 2015 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients who visited Tenri Hospital, Nara Medical University from Nov. 6, 2015 and met the inclusion criteria without meeting any of the exclusion criteria in addition to be able to provide written informed consent were enrolled. This study is a cross-sectional study.
After completion of this study, the new self-efficacy questionnaire will be used to measure key outcomes in a clinical study (The COMparison of satisfaction between patient-led and physician-led titration group Measured by a new questionnaire In Japanese T2D patients [COMMIT-patient study]) where glargine 300U/mL is used as a study drug.
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2017 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023172
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
