UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017513
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mhazumi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.