UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024400 |
|---|---|
| Receipt number | R000027251 |
| Scientific Title | The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2017/10/16 09:26:21 |
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Basic information
Public title
The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Acronym
The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Scientific Title
The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Scientific Title:Acronym
The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the feasibility and the continuity of the lifestyle modification program with Information and Communication Technology (ICT) and home medical equipment to reduce sodium intake and increase potassium intake, and to improve the data management and support system.
Basic objectives2
Others
Basic objectives -Others
To establish the infrastructure to implement the lifestyle modification program to the large number of subjects
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
sodium-potassium ratio in the urine
Key secondary outcomes
estimated sodium intake, estimated potassium intake, blood pressure, test of salty taste, frequency of usage of home medical equipment,etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
In order to to reduce salt intake and increase potassium intake, doctors individually interview participants 4 times for 4 months and send a letter once. Home medical equipment for blood pressure and sodium potassium ratio are used, and the data are collected via internet with mobile phones.
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Being possible to understand the content of the study and give the written consent
(2)Blood pressure at the last health checkup
Systolic :130-139 mmHg
Diastolic: 89 mmHg or less
(3)Renal function at the last health checkup
eGFR: 60 ml/min/1.73m2 or more
urine test: no proteinuria
Key exclusion criteria
(1)Medication for hypertension, dyslipidemia, diabetes, hyperuricemia etc.
(2)Past history of angina, myocardial infarction, stroke
(3)Past history of diseases influencing electrolyte in the blood
(4)Being judged inappropriate as study participants by corresponding doctors
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyamoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Preventive Cardiology
Zip code
Address
5-7-1, Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
miyamoty@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
National Cerebral and Cardiovascular Center
Division name
Preventive Cardiology
Zip code
Address
5-7-1, Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
makotow@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center, Preventive Cardiology
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
FUJITSU LIMITED
OMRON HEALTHCARE Co., Ltd.
Name of secondary funder(s)
FUJITSU LIMITED
OMRON HEALTHCARE Co., Ltd.
IRB Contact (For public release)
Organization
Address
Tel
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
国立循環器病研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | 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
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
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 13 | Day |
Last modified on
| 2017 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027251
