UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051681
Receipt number R000058975
Scientific Title Effect of Hospital Pharmacist Collaboration on Solving Pharmacotherapy Problems in Stroke Patients with Changes in Medical Care Environment "Randomaized Controlled Trial"
Date of disclosure of the study information 2023/07/24
Last modified on 2024/01/22 14:06:15

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Basic information

Public title

Effect of Hospital Pharmacist Collaboration on Solving Pharmacotherapy Problems in Stroke Patients with Changes in Medical Care Environment "Randomaized Controlled Trial"

Acronym

HCPC-Study-Stroke RCT

Scientific Title

Effect of Hospital Pharmacist Collaboration on Solving Pharmacotherapy Problems in Stroke Patients with Changes in Medical Care Environment "Randomaized Controlled Trial"

Scientific Title:Acronym

HCPC-Study-Stroke RCT

Region

Japan


Condition

Condition

stroke

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Identifying the impact of biderectonal patient information sharing between hospital pharmacists and community pharmacists on post-discharge medication adherence in stroke patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage of pre-and-post discharge medication discrepancies that may increase the risk of recurrent stroke

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Two-way sharing of patient infomation between hospital pharmacists and community pharmacists using online tools

Interventions/Control_2

usual care (no sharing of patient infomation between hospital pharmacists and community pharmacist)

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with stroke (cerebral infarction) who transferred to convalescent wards after acute treatment and visit other hospitals

Key exclusion criteria

Patients who do not have family pharmacy at the time of admission
Patients who was prescribed no medication at discharge
Others who are deemed ineligible by the research director or research collaborators

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Fukuda
Middle name
Last name Yuko

Organization

JCHO Hoshigaoka Medical Center

Division name

phaemaceutical department

Zip code

573-0013

Address

4-8-1 hoshigaoka hirakata city osaka

TEL

0728402641

Email

fukuda-yuko@hoshigaoka.jcho.go.jp


Public contact

Name of contact person

1st name Fukuda
Middle name
Last name Yuko

Organization

JCHO Hoshigaoka Medical Center

Division name

phaemaceutical department

Zip code

573-0013

Address

4-8-1 hoshigaoka hirakata city osaka

TEL

0728402641

Homepage URL


Email

fukuda-yuko@hoshigaoka.jcho.go.jp


Sponsor or person

Institute

JCHO Hoshigaoka Medical Center

Institute

Department

Personal name



Funding Source

Organization

JCHO Hoshigaoka Medical Center

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

JCHO Hoshigaoka Medical Center Clinical Reserch and Ckinical Trial Management Office

Address

4-8-1 hoshigaoka hirakata city osaka

Tel

0728402641

Email

nakano-megumi@hoshigaoka.jcho.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

2023 Year 07 Month 24 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

2023 Year 06 Month 26 Day

Date of IRB

2023 Year 06 Month 26 Day

Anticipated trial start date

2023 Year 07 Month 24 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 07 Month 21 Day

Last modified on

2024 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name