UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017513 |
|---|---|
| Receipt number | R000020301 |
| Scientific Title | Medication adherence and continuity of care (Observational study of impact of medication adherence on renal function in comorbid patients with type 2 diabetes and depression) |
| Date of disclosure of the study information | 2015/05/22 |
| Last modified on | 2020/05/15 09:17:38 |
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Basic information
Public title
Medication adherence and continuity of care (Observational study of impact of medication adherence on renal function in comorbid patients with type 2 diabetes and depression)
Acronym
Observational study on diabetes and depression
Scientific Title
Medication adherence and continuity of care (Observational study of impact of medication adherence on renal function in comorbid patients with type 2 diabetes and depression)
Scientific Title:Acronym
Observational study on diabetes and depression
Region
| Japan |
Condition
Condition
Diabetes and depression
Classification by specialty
| Endocrinology and Metabolism | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine depression as a predictor of renal function decline, and how adherence to hypoglycemic medication relates to depression and renal function decline in patients with type 2 diabetes
Basic objectives2
Others
Basic objectives -Others
Decline of renal function in subtypes categorized according to depression and adherence
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Decline of renal function in subtypes categorized according to depression and adherence
Key secondary outcomes
Clinical variables, quality of life, and attitude of physicians toward depression
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
Outpatients with type 2 diabetes receiving hypoglycemic medications who can complete a questionnaire in Japanese.
Key exclusion criteria
Patients pregnant, with cognitive impairment, severe disease of the adrenal glands, liver dysfunction, or severe renal impairment (serum creatinine > 2.0 mg/dL)
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Hazumi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Mental Health Policy and Evaluation, National Institute of Mental Health
Zip code
187-0031
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
ItoHiroto@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Hazumi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Mental Health Policy and Evaluation, National Institute of Mental Health
Zip code
187-0031
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
mhazumi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
mhazumi@ncnp.go.jp
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
国立精神・神経医療研究センター病院（東京都）、京都医療センター（京都府）、医療法人社団シマダ嶋田病院（福岡県）、自治医科大学病院（栃木県）、大阪赤十字病院（大阪府）、松原病院（福井県）、不知火病院（福岡県）、草津病院（広島県）、可也病院（福岡県）、仁大病院（愛知県）、養南病院（岐阜県）、阪南病院（大阪府）、しのだの森ホスピタル（千葉県）、宇治おうばく病院（京都府）、あさかホスピタル（福島県）、東京医科大学（東京都）、久留米大学（福岡県）、聖ルチア病院（福岡県）、たかむきメンタルクリニック（福岡県）、宮の陣病院（福岡県）、広田クリニック（福岡県）、のぞえ総合心療病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.biomedcentral.com/1471-2296/16/124/prepub
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020301
