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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026328
Receipt No. R000030238
Scientific Title Validation study of the Diabetes Treatment Burden Questionnaire (DTBQ)
Date of disclosure of the study information 2017/02/28
Last modified on 2018/08/31

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Basic information
Public title Validation study of the Diabetes Treatment Burden Questionnaire (DTBQ)
Acronym Validation study of the Diabetes Treatment Burden Questionnaire (DTBQ)
Scientific Title Validation study of the Diabetes Treatment Burden Questionnaire (DTBQ)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hitoshi Ishii
Organization Nara Medical University
Division name Department of Diabetology
Zip code
Address 840 Shijo-Cho, Kashihara, Nara, Japan
TEL 0744-22-3051
Email hits1@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ishii
Organization Nara Medical University
Division name Department of Diabetology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984917/
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
2016 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000030238

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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