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

Email



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

Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name