UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001920
Receipt number R000002340
Scientific Title The relationship between adherence and patients' subjective satisfaction with physicians' interview: a prospective cohort study
Date of disclosure of the study information 2009/04/30
Last modified on 2009/04/30 16:34:00

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Basic information

Public title

The relationship between adherence and patients' subjective satisfaction with physicians' interview: a prospective cohort study

Acronym

Adherence and patients' satisfaction with physicians' interview

Scientific Title

The relationship between adherence and patients' subjective satisfaction with physicians' interview: a prospective cohort study

Scientific Title:Acronym

Adherence and patients' satisfaction with physicians' interview

Region

Japan


Condition

Condition

Depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of patients' satisfaction with the physicians' interview on persistence and medication compliance

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Medication Interview Satisfaction Scale
Persistence
Compliance

Key secondary outcomes

Social Adaptation Self-evaluation Scale
W&SAS
MADRS, QIDS-16-SR


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Diagnosis with a major depressive disorder according to the ICD-10: F32-33
Had not received any antidepressants within the past 6 months

Key exclusion criteria

Unstable physical conditions that required treatment
Substance use

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norifusa SAWADA

Organization

Saiseikai Central Hospital

Division name

Psychiatry

Zip code


Address

1-4-17, Mita, Minato-ku, Tokyo

TEL

03-3451-8211

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

Department of Neuropsychiatry

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

School of Medicine, Keio University
Department of Neuropsychiatry

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

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



Other administrative information

Date of disclosure of the study information

2009 Year 04 Month 30 Day


Related information

URL releasing protocol


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

Date of protocol fixation

2009 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will investigate adherence of depression


Management information

Registered date

2009 Year 04 Month 30 Day

Last modified on

2009 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name