UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062657 |
|---|---|
| Receipt number | R000070521 |
| Scientific Title | Effect of salt-reduction support at community pharmacies on home systolic blood pressure: a pharmacy-cluster, two-period, two-sequence crossover trial |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/22 16:19:39 |
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Basic information
Public title
Effect of salt-reduction support at community pharmacies on home systolic blood pressure: crossover trial
Acronym
COMPASS Salt-Reduction Trial
Scientific Title
Effect of salt-reduction support at community pharmacies on home systolic blood pressure: a pharmacy-cluster, two-period, two-sequence crossover trial
Scientific Title:Acronym
COMPASS Salt-Reduction Trial
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether the provision of low-salt foods and brief pharmacist-led information on salt reduction at community pharmacies improves home systolic blood pressure among patients receiving oral antihypertensive treatment, compared with a control period involving home blood pressure monitoring alone. The study will also assess changes in knowledge, attitudes, and confidence regarding lifestyle behaviors for blood pressure control, as well as step counts and body weight, to examine the feasibility of implementing this blood pressure management support program in community pharmacies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in home systolic blood pressure between the intervention period and the control period. Home systolic blood pressure will be evaluated using the mean value during each period, based on morning and evening home blood pressure measurements, or the within-period change. The primary analysis will include participants who complete at least 70% of the scheduled home blood pressure measurements.
Key secondary outcomes
1. Changes in scores for knowledge, attitudes, and confidence regarding lifestyle behaviors for blood pressure control, including salt reduction, from baseline to the end of the study
2. Changes in step counts
3. Changes in body weight
4. Adherence to the intervention meals
5. Home blood pressure monitoring
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sequence AB: During the intervention period, participants replace one meal per day, preferably dinner, with a low-salt food, low-salt soup, and 150 g of rice for 5 days. On the first day, a pharmacist provides brief education on salt reduction using a leaflet for approximately 3 minutes. Participants record morning and evening home blood pressure, body weight, step counts, and meal timing. After a 2-day washout period, participants enter the control period and perform home blood pressure monitoring only for 7 days.
Interventions/Control_2
Sequence BA: During the control period, participants perform home blood pressure monitoring only for the first 7 days. After a 2-day washout period, participants enter the intervention period and replace one meal per day, preferably dinner, with a low-salt food, low-salt soup, and 150 g of rice for 5 days. On the first day, a pharmacist provides brief education on salt reduction using a leaflet for approximately 3 minutes. Participants record morning and evening home blood pressure, body weight, step counts, and meal timing.
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
Adults aged 20 years or older
Patients taking oral antihypertensive medication and regularly visiting a participating community pharmacy
Patients who measure home blood pressure or are able to perform home blood pressure monitoring during the study period
Patients who understand the study explanation and provide written informed consent
Key exclusion criteria
Patients who are expected to have difficulty continuing participation during the study period, such as due to relocation
Patients requiring strict dietary restrictions, including salt or protein restriction, because of severe cardiac disease, renal disease, or other serious conditions
Patients who are pregnant or may be pregnant
Patients judged by the principal investigator or study staff to be inappropriate for participation in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okada |
Organization
National Hospital Organization Kyoto Medical Center, Clinical Research Center
Division name
Department of Preventive Medicine
Zip code
612-0861
Address
1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto
TEL
0756419161
okada.hiroshi.28z@kyoto-u.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okada |
Organization
National Hospital Organization Kyoto Medical Center, Clinical Research Center
Division name
Preventive Medicine
Zip code
612-0861
Address
1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
okada.hiroshi.28z@kyoto-u.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Hiroshi Okada
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Pharmacy Association
Address
1-6-23 Meguro Meguro-ku, Tokyo
Tel
03-6303-9181
info@ja-cp.org
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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 08 | Month | 22 | Day |
Last modified on
| 2026 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070521
