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

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 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

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

Value
https://center6.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