UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation study of the Diabetes Treatment Burden Questionnaire (DTBQ)
Title of the study (Brief title)	Validation study of the Diabetes Treatment Burden Questionnaire (DTBQ)
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop the DTBQ and investigate the reliability and the validity of this scale
Basic objectives2	Others
Basic objectives -Others	development of patient reported questionnaire
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Diabetes Treatment Burden Questionnaire (DTBQ)
Key secondary outcomes	Diabetes Treatment Satisfaction Questionaire (DTSQ)

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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients are eligible only if they meet all of the following criteria: 1. Out patients (type 2 diabetes) who have pharmacotherapy >=12 weeks. 2. Male and female aged >=20 years. 3. Patients who give written informed consent to participate in the study.
Key exclusion criteria	Patients will be excluded from the study if they meet any of the following criteria: 1. Patients who have dementia, are possibly demented, or suffered from psychiatric disorder. 2. Patients who are not competent 3. Patients who need consent from legal representative 4. Patients who are inappropriate judged by investigators in any other condition
Target sample size	210

Research contact person
Name of lead principal investigator	Hitoshi Ishii
Organization	Nara Medical University
Division name	Department of Diabetology
Address	840 Shijo-Cho, Kashihara, Nara, Japan
TEL	0744-22-3051
Email	hits1@naramed-u.ac.jp

Public contact
Name of contact person	Hitoshi Ishii
Organization	Nara Medical University
Division name	Department of Diabetology
Address	840 Shijo-Cho, Kashihara, Nara, Japan
TEL	0744-22-3051
Homepage URL
Email	hits1@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Eli Lilly Japan 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	奈良県立医科大学（奈良県） しんクリニック（東京都） 羽賀糖尿病内科（愛知県） 糖尿病・内分泌内科クリニックTOSAKI（愛知県） なかじま糖尿病内科（大阪府） 白岩内科医院（大阪府） 渡辺内科クリニック（兵庫県）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 07 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984917/
Results
Other related information	The questionnaire survey will be conducted

Management information
Registered date	2017 Year 02 Month 28 Day
Last modified on	2018 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030238