UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005302 |
|---|---|
| Receipt number | R000006246 |
| Scientific Title | Development of brief and step by step individualized lifestyle modification for hypertensive patients |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2018/04/02 11:53:30 |
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Basic information
Public title
Development of brief and step by step individualized lifestyle modification for hypertensive patients
Acronym
BASIL study
Scientific Title
Development of brief and step by step individualized lifestyle modification for hypertensive patients
Scientific Title:Acronym
BASIL study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the effectiveness of brief and step by step individualized lifestyle modification program (BASIL) for hypertensive patients in general practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serial changes in BP between the baseline and 12 weeks after the initial intervention
Key secondary outcomes
1.Serial changes between the baseline and 12 weeks after the initial intervention
1-1) Dietary salt intake estimated by spot urine
1-2) Body mass index
1-3) Stage-of-change in salt reduction and exercise
1-4) Physical activity (IPAQ short version)
1-5) Self efficacy in salt reduction
1-6) Health-related quality of life (SF-8)
1-7) Serum levels of triglycerides, LDL cholesterol, HDL cholesterol, HbA1c
2. Others
2-1) Time spent with a doctor
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Brief and Step-by-step Individualized Lifestyle modification program (BASIL) for hypertensive patients
Duration; June 2012 - May 2013
Frequency; 3 times per 3 months (2 weeks, 6 weeks, 12 weeks after the baseline assessment)
Length of each intervention; 5-10 minutes
Interventions/Control_2
Usal care
Duration; April 2011 - March 2012
Frequency; voluntarily
Length of each intervention; voluntarily
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must fulfill all of the following criteria.
1) mean systolic BP is 140-159mmHg
2) 20-64 years old
3) no previous medication within a year.
Key exclusion criteria
Patients who fulfill one of the following criteria must be excluded:
1) secondary hypertension
2) diabetes
3) dementia
4) history of cardio-cerebral disease
5) atrial fibrillation
6) complaining fever or acute pain
7) being in hospital or nursing home
8) mean diastolic BP is over 110mmHg
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Tsugihashi |
Organization
Tenri Hospital
Division name
Department of General Internal Medicine
Zip code
Address
200, Mishima, Tenri City, Nara 632-8552, Japan
TEL
+81-743-63-5611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Tsugihashi |
Organization
Tenri Hospital
Division name
Department of General Internal Medicine
Zip code
Address
200, Mishima, Tenri City, Nara 632-8552, Japan
TEL
+81-743-63-5611
Homepage URL
http://plaza.umin.ac.jp/basil/index.html
y.next.t@tenriyorozu-hp.or.jp
Sponsor or person
Institute
Department of General Internal Medicine, Tenri Hospital
Institute
Department
Personal name
Funding Source
Organization
St.Luke`s Life Science Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto University Graduate School of Medicine and Public Health, Department of Epidemiology and Healthcare Research
Name of secondary funder(s)
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
天理よろづ相談所病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
| 2011 | Year | 03 | Month | 24 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006246
