UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062015 |
|---|---|
| Receipt number | R000070965 |
| Scientific Title | Implementation of Co-Designed Patient Educational Materials in Community Pharmacies: Impact on Pharmacists' KAP and Patient Blood Pressure Control Evaluated by a Linear Mixed Model |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/07/09 01:22:39 |
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Basic information
Public title
Implementation of Patient-Tailored Antihypertensive Educational Materials in Community Pharmacies: Impact on Pharmacists' KAP and Patient Blood Pressure Control
Acronym
Community Pharmacy QI for Hypertension Management
Scientific Title
Implementation of Co-Designed Patient Educational Materials in Community Pharmacies: Impact on Pharmacists' KAP and Patient Blood Pressure Control Evaluated by a Linear Mixed Model
Scientific Title:Acronym
Evergreen Pharmacy 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
Changes in pharmacists' KAP (Knowledge, Attitudes and Practices) scores
(Assessment periods: baseline [prior to the introduction of the materials] and at the end of the 4-month follow-up [4 months after the introduction of the materials])
*Knowledge, attitudes and practices were assessed as continuous variables using structured questionnaires, and a paired t-test was applied as the primary analysis.
Key secondary outcomes
Degree of standardisation in patient-facing practices (medical record documentation rate): Presence or absence of entries in medical records regarding guidance using educational materials and blood pressure checks (baseline vs. 4 months later). The McNemar test will be applied.
Time-course trends in patients' morning home blood pressure (exploratory analysis): Blood pressure trends at baseline, 2 months, 3 months and 4 months post-intervention will be analysed using a linear mixed model (LMM).
*Note: When selecting the analysis population, an automated classification algorithm based on the WHO ATC/DDD system will be used to objectively screen for and exclude confounding factors, such as changes in prescriptions.
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
Pharmacists (23 in total) working at participating Evergreen Pharmacy branches, and adult patients currently undergoing treatment for hypertension who visit the pharmacy regularly and from whom morning home blood pressure data can be obtained.
Key exclusion criteria
Patients who have opted out of data use, or cases where a significant change in clinical condition or difficulty in continuing medication has been observed.
Target sample size
23
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
Open public recruiting
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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2027 | Year | 02 | Month | 28 | 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 | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070965
