UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057066 |
|---|---|
| Receipt number | R000065176 |
| Scientific Title | A Comparative Trial of Salt Reduction Guidance by Nurse Practitioners and Physicians |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2026/02/19 22:21:13 |
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Basic information
Public title
Comparison of the Blood Pressure-Lowering Effects of Salt Reduction Guidance for Hypertensive Patients Between Physicians and Nurse Practitioners
Acronym
NP-Dr Salt Trial
Scientific Title
A Comparative Trial of Salt Reduction Guidance by Nurse Practitioners and Physicians
Scientific Title:Acronym
NP-SALT
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of individualized salt reduction advice by NPs for hypertensive patients in reducing salt intake, lowering blood pressure, improving adherence, and reducing clinical inertia compared to standard salt reduction advice by doctors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salt intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
NP intervention group
Interventions/Control_2
Dr intervention group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with independent Activities of Daily Living (ADL).
Individuals who can measure their own blood pressure and manage their records.Individuals who have provided consent to participate in this study by signing the informed consent form.
Key exclusion criteria
Patients with secondary hypertension.
Patients aged 80 years or older.
Patients with cognitive impairment.
Individuals with a history of myocardial infarction.
Individuals with severe liver disease .
Individuals with severe kidney disease .
Pregnant women or women with the possibility of pregnancy.
Breastfeeding women.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | TOSHIYUKI |
| Middle name | |
| Last name | OJIMAOJIMA |
Organization
Hamamatsu University School of Medicine
Division name
Community Health & Preventive Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Japan
TEL
0534352111
ojima@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | tomomi |
| Middle name | |
| Last name | shozuhara |
Organization
SHIMIZURYOGOCHICLINIC
Division name
no
Zip code
4240403
Address
693-1wadashima shimizu-ku sizuoka city shizuoka japan
TEL
0543432388
Homepage URL
azukichan8@gmail.com
Sponsor or person
Institute
shimizuryogochiclinic
Institute
Department
Personal name
tomomi shozuhara
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Japan
Tel
0534352680
rinri@hama-med.ac.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
| 2025 | Year | 02 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065176
