UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062015 |
|---|---|
| Receipt number | R000070965 |
| Scientific Title | Implementation of a Multicenter Quality Improvement Initiative for Hypertension Management: Does Pharmacy Scale Affect Pharmacist Attitudinal Changes and Clinical Outcomes? |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/24 13:39:07 |
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Basic information
Public title
Implementation of Hypertension and Lifestyle Counseling in Community Pharmacies: A Multi-Center Collaborative Quality Improvement (QI) Project for Pharmacist Counseling
Acronym
Implementation of Hypertension and Lifestyle Counseling in Community Pharmacies
Scientific Title
Implementation of a Multicenter Quality Improvement Initiative for Hypertension Management: Does Pharmacy Scale Affect Pharmacist Attitudinal Changes and Clinical Outcomes?
Scientific Title:Acronym
EG-Hypertension QI Study
Region
| Japan |
Condition
Condition
Hypertension, Lifestyle-related diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the impact of using original patient education materials on pharmacists' awareness of hypertension management, specifically regarding salt reduction, aerobic exercise, moderation in drinking, weight loss, and dietary improvements, as well as on their medication counseling practices (Quality Improvement), while also assessing changes in patients' home blood pressure.
Furthermore, to evaluate how pharmacy scale and resource environments (Large, Medium, and Small) affect the implementation and outcomes of this initiative, a stratified analysis by facility size will be conducted. This study ultimately aims to verify the effectiveness and universal reproducibility of QI activities in resource-limited environments.
Basic objectives2
Others
Basic objectives -Others
Evaluation of quality improvement (QI) in pharmacy medication counseling and the impact of pharmacy scale (resource environments) on its implementation viability.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The longitudinal changes in morning home blood pressure (systolic and diastolic blood pressure) measured in accordance with the JSH 2019 guidelines at 2, 3, and 4 months after the initiation of intervention (Month 0: baseline). To mathematically adjust for the unequal measurement intervals during the initial 2-month habituation period, a linear mixed-effects model will be applied for statistical analysis.
Key secondary outcomes
Changes in pharmacists' KAP questionnaire scores between pre-intervention (Month 0) and post-intervention (Month 4). The completion rate of blood pressure documentation and specific lifestyle counseling in pharmacy medical logs at 2, 3, and 4 months after the initiation of intervention. A stratified comparison among the three pharmacy scale groups.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pharmacy records of patients who meet all of the following criteria will be included:
Adult patients aged 20 years or older.
Diagnosed with hypertension and prescribed antihypertensive medications.
Visited the target pharmacies [on a regular monthly basis (approximately 4-week to 1-month intervals)] during the study period and received medication counseling (intervention) at least once using the original patient education materials.
Capable of or willing to perform morning home blood pressure monitoring at home.
Key exclusion criteria
Pharmacy records of patients who meet any of the following criteria will be excluded from the analysis:
Patients who are judged to have extreme difficulty in accurately understanding or implementing medication counseling and home blood pressure monitoring using the original patient education materials due to acute psychiatric illness or worsening dementia.
Patients who are currently participating in other clinical studies or interventional trials that could affect the data extraction of this study.
Other patients deemed inappropriate for data extraction (tracking of pharmacy records) by the attending pharmacist (e.g., transfer to another pharmacy due to relocation, or discontinuation of the intervention during the study period).
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Mori |
Organization
Evergreen Hirojin Co., Ltd.
Division name
Evergreen Pharmacy koya
Zip code
640-8435
Address
82-1 Koya, Wakayama Shi, Wakayama Ken
TEL
073-480-6800
ebakoya-4886381@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Mori |
Organization
Evergreen Hirojin Co., Ltd.
Division name
Evergreen Pharmacy koya
Zip code
640-8435
Address
82-1 Koya, Wakayama Shi, Wakayama Ken
TEL
073-480-6800
Homepage URL
ebakoya-4886381@umin.ac.jp
Sponsor or person
Institute
Evergreen Hirojin Co., Ltd.
Institute
Department
Personal name
Takeshi Mori
Funding Source
Organization
Evergreen Hirojin Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Pharmacists Association Research Ethics Committee
Address
3F Ota Bldg, 2-14-9 Ota, Wakayama-shi, Wakayama
Tel
073-473-5353
info@wakayakushin.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
エバグリーン薬局古屋店（和歌山県）, エバグリーン薬局新中島店（和歌山県）, エバグリーン薬局宮街道店（和歌山県）, エバグリーン薬局福島店（和歌山県）, エバグリーン薬局和佐店（和歌山県）, エバグリーン薬局高野口店（和歌山県）, エバグリーン薬局狭山店（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | 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
No
IPD sharing Plan description
The data obtained in this study will be used exclusively for quality improvement (QI) activities within the Evergreen Pharmacy Group and for academic presentations. There is no plan to share individual participant data (IPD) externally.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2026 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is a multicenter, prospective observational study (Quality Improvement activity) conducted across 7 branches of the Evergreen Pharmacy Group.
It is a descriptive survey to extract and aggregate data on blood pressure values and medication adherence from pharmacy records of patients who received specific educational materials (leaflets promoting salt reduction, aerobic exercise, moderation in drinking, weight loss, dietary improvements, and home blood pressure monitoring) during routine operations. No experimental assignments, such as new clinical interventions or randomization for research purposes, are performed.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070965
