UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049645 |
|---|---|
| Receipt number | R000056269 |
| Scientific Title | Effect of active two-way information sharing between physicians and pharmacists on blood pressure treatment |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/11/30 15:37:32 |
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Basic information
Public title
Effect of physician-pharmacist information sharing on blood pressure
Acronym
Effect of physician-pharmacist information sharing on blood pressure
Scientific Title
Effect of active two-way information sharing between physicians and pharmacists on blood pressure treatment
Scientific Title:Acronym
Effect of active two-way information sharing between physicians and pharmacists on blood pressure treatmen
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether two-way information sharing between physicians and pharmacists can improve lifestyle and medication adherence and contribute to lowering blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in systolic blood pressure at baseline and at the end of the study.
Key secondary outcomes
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
5 months intervention in lifestyle
modification (salt reduction, exercise, weight loss, dietary patterns, smoking cessation and sobriety).
Residual medication adjustment for 5 months
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients on antihypertensive medication with office blood pressure of 130/80mmHg or higher (with or without comorbidities).
Key exclusion criteria
Patients with an office systolic blood pressure >179mmHg and/or diastolic BP >109mmHg.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Yuasa |
Organization
Kanagawa Physicians Association
Division name
Drug Evaluation review Committee
Zip code
231-0037
Address
3-1, Naka-ku, Yokohama City, Kanagawa, Japan
TEL
045-241-7000
shohei.clinic@cocoa.plala.or.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Iwasawa |
Organization
Yokosuka General Hospital Uwamachi
Division name
Cardiology
Zip code
238-8567
Address
2-36, Uwamachi, Yokosuka city, Kanagawa, Japan
TEL
046-823-2630
Homepage URL
iwasawat@jadecom.jp
Sponsor or person
Institute
Kanagawa Physicians Association
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Physicians Association
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
Kanagawa Prefecture Medical Association
Address
3-1, Naka-ku, Yokohama City, Kanagawa, Japan
Tel
0452417000
k-arai@kanagawa.med.or.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
| 2022 | Year | 12 | 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
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
| 2022 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2022 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
