UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the self-efficacy questionnaire for insulin users (Study)
Title of the study (Brief title)	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	Hitoshi Ishii
Organization	Nara Medical University
Division name	Department of Diabetology
Address	840 Shinjouchou, Kashihara-shi, Nara
TEL	0744-22-3051
Email	hits1@naramed-u.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Japan Society for Patient Reported Outcome (PRO)
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023172