UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026618
Receipt number R000030570
Scientific Title the effectiveness of medication instructions for medication adherence in psychiatric patients
Date of disclosure of the study information 2017/03/22
Last modified on 2021/09/22 17:57:04

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Basic information

Public title

the effectiveness of medication instructions for medication adherence in psychiatric patients

Acronym

the effectiveness of medication instructions for medication adherence in psychiatric patients

Scientific Title

the effectiveness of medication instructions for medication adherence in psychiatric patients

Scientific Title:Acronym

the effectiveness of medication instructions for medication adherence in psychiatric patients

Region

Japan


Condition

Condition

Diagnosis of psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify how medication instruction by pharmacist affects medication adherence in patients with psychiatric disorders.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Drug Attitude Inventory-30
(At hospitalization,At the start of taking medicine myself,At the start of medication instruction,At discharge)

Key secondary outcomes

Drug Attitude Inventory-10
(At hospitalization,At the start of taking medicine myself,At the start of medication instruction,At discharge)
Adherence confirmed by the pill count method


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Starting taking medicine by self-management from the time the doctor judges it possible.
After 2 weeks taking medicine by self-management, pharmacists conducted medication instruction until discharge.

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

Patient who the attending physician judged possible to participate.
Received informed consent.

Key exclusion criteria

Patient who the attending physician judged impossible to participate.
Unreceived informed consent.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Tokutani

Organization

The Hospital of Hyogo College of Medicine

Division name

Department of pharmacy

Zip code

663-8501

Address

1-1 Mukogawacho,Nishinomiya,Hyogo,Japan

TEL

0798-45-6189

Email

yktokuta@hyo-med.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Tokutani

Organization

The Hospital of Hyogo College of Medicine

Division name

Department of pharmacy

Zip code

658-8501

Address

1-1 Mukogawacho,Nishinomiya,Hyogo,Japan

TEL

0798-45-6189

Homepage URL


Email

yktokuta@hyo-med.ac.jp


Sponsor or person

Institute

Department of pharmacy,The Hospital of Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of pharmacy,The Hospital of Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Hospital of Hyogo College of Medicine

Address

1-1 Mukogawacho,Nishinomiya,Hyogo,Japan

Tel

0798-45-6006

Email

chiken02@hyo-med.ac.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



Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 22 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

Enrolling by invitation

Date of protocol fixation

2015 Year 10 Month 14 Day

Date of IRB

2015 Year 10 Month 14 Day

Anticipated trial start date

2015 Year 10 Month 14 Day

Last follow-up date

2030 Year 10 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 20 Day

Last modified on

2021 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name