UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026328 |
|---|---|
| Receipt number | 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 13:39:09 |
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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
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
hits1@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030238
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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