UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000049381
Receipt number R000056212
Scientific Title Observational Study of Physicians' Perceptions of Hypertension Treatment with a Hypertension Treatment Aid App
Date of disclosure of the study information 2022/11/01
Last modified on 2023/08/04 12:39:57

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Basic information

Public title

Observational Study of Physicians' Perceptions of Hypertension Treatment with a Hypertension Treatment Aid App

Acronym

HERB-DP Study

Scientific Title

Observational Study of Physicians' Perceptions of Hypertension Treatment with a Hypertension Treatment Aid App

Scientific Title:Acronym

HERB-DP Study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Determine the impact of CureApp HT on the sharing of blood pressure targets and treatment objectives between physicians and patients.

Basic objectives2

Others

Basic objectives -Others

Physician Perception Survey

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

sharing of blood pressure targets

Key secondary outcomes



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

Physicians with experience treating essential hypertension

Physicians who can use CureApp HT

Key exclusion criteria

Previously treated with CureAppHT
Has had a repeat visit for treatment with CureAppHT prior to participation in this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Katsuya

Organization

Katsuyaiin

Division name

Katsuyaiin

Zip code

6600052

Address

2-17-21,Nanamatsucho,Amagasaki-si,Hyogo

TEL

06-6416-1684

Email

tkatsuya@iris.eonet.ne.jp


Public contact

Name of contact person

1st name Fumi
Middle name
Last name Hisaki

Organization

CureApp,inc

Division name

Medical&RegulatoryAffairs Department

Zip code

1030001

Address

4F12-5,Nihonbashikodenmacho,Chio-ku,Tokyo.Japan

TEL

0362310183

Homepage URL


Email

fumi.hisaki@cureapp.jp


Sponsor or person

Institute

katsuyaiin

Institute

Department

Personal name



Funding Source

Organization

CureApp,inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

KitamachiShinryojo rinrishinsaiinkai

Address

1-1-3,KichijojiKitamachi,Musashino-si.Tokyo

Tel

03-6779-8116

Email

chi-pr-ec-kitamachi@cmicgroup.com


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

2022 Year 11 Month 01 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

152

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

2022 Year 10 Month 06 Day

Date of IRB

2022 Year 10 Month 26 Day

Anticipated trial start date

2022 Year 11 Month 01 Day

Last follow-up date

2024 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Status of sharing blood pressure targets with patients

Status of sharing the goal of hypertension treatment with the patient


Management information

Registered date

2022 Year 10 Month 31 Day

Last modified on

2023 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name