UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063481 |
|---|---|
| Receipt number | R000072590 |
| Scientific Title | Changes in Home Blood Pressure Following a Blood Pressure Follow-up Sheet-Based Intervention by Community Pharmacists |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/30 21:24:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study of Community Pharmacist Support for Home Blood Pressure Using a Blood Pressure Follow-up Sheet
Acronym
A Study of Community Pharmacist Support for Home Blood Pressure Using a Blood Pressure Follow-up Sheet
Scientific Title
Changes in Home Blood Pressure Following a Blood Pressure Follow-up Sheet-Based Intervention by Community Pharmacists
Scientific Title:Acronym
Blood Pressure Follow-up Sheet Intervention Study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement blood pressure management in community pharmacies in accordance with the 2025 Japanese guidelines for the management and treatment of hypertension, community pharmacists use a blood pressure follow-up sheet to systematically assess home blood pressure, medication use, subjective symptoms, and other relevant factors, and provide information to physicians as needed. This study aims to evaluate changes in home blood pressure before and after the intervention and to examine the attainment of blood pressure targets, prescription changes, recommendations made by pharmacists to physicians, and challenges associated with the use of the follow-up sheet
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in home systolic and diastolic blood pressure from the initial assessment using the blood pressure follow-up sheet to the single follow-up assessment conducted after the subsequent medical consultation. The interval to follow-up varied among patients.
Key secondary outcomes
Proportion of patients who achieved the home blood pressure target after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Blood pressure management support by community pharmacists using a blood pressure follow-up sheet
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients receiving medication indicated for hypertension who were able to measure and manage home blood pressure.
2. Patients aged 18 years or older who personally consented to participate in the study.
3. Patients with home blood pressure of at least 125/75 mmHg or office blood pressure of at least 130/80 mmHg at the start of the intervention.
Key exclusion criteria
1. Patients who did not consent to participation or withdrew consent.
2. Patients whose medication was collected by a proxy without the patient visiting the pharmacy.
3. Patients judged by the pharmacist to be unable to undergo the sheet-based intervention or medication follow-up because of cognitive impairment.
4. Patients unable to measure or record blood pressure.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | NAOTO |
| Middle name | |
| Last name | KIMURA |
Organization
MEDICAL SYSTEM NETWORK Co.,Ltd.
Division name
Nanohana East Japan Nanohana Pharmacy Satsuki Store
Zip code
1130022
Address
2-2-16 Sendagi, Bunkyo-ku, Tokyo
TEL
0358348170
naoto.kimura.nhe@msnw.co.jp
Public contact
Name of contact person
| 1st name | NAOTO |
| Middle name | |
| Last name | KIMURA |
Organization
MEDICAL SYSTEM NETWORK Co.,Ltd.
Division name
Nanohana East Japan Nanohana Pharmacy Satsuki Store
Zip code
1130022
Address
2-2-16 Sendagi, Bunkyo-ku, Tokyo
TEL
0358348170
Homepage URL
naoto.kimura.nhe@msnw.co.jp
Sponsor or person
Institute
MEDICAL SYSTEM NETWORK Co.,Ltd Nanohana East Japan Nanohana Pharmacy Satsuki Store
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Committee of the Hokkaido Institute of Pharmaceutical Sciences
Address
AKK Building, 2-1 Kita 10-jo Nishi 24-chome, Chuo-ku, Sapporo, Hokkaido
Tel
0116121069
rinri-shinsa@iyakusoken.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
| 2026 | 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
37
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
Completed
Date of protocol fixation
| 2026 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2026 | Year | 10 | Month | 30 | Day |
Last modified on
| 2026 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072590
