The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension

This study has been completed.

First Received: April 10, 2007 No Changes Posted

Sponsor:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00459017

Purpose

Despite knowledge regarding the importance of controlling patients' blood pressure (BP) only 30% of treated patients achieve BP goals. Our objective was to determine the effect of frequent self measurements of BP in the patients' natural environment as a mean to improve BP control. Our hypothesis was that frequent measurements of BP will reduce mean BP levels.

Condition	Intervention	Phase
Hypertension	Device: Portable blood pressure wrist manometer	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Meam blood pressure

Secondary Outcome Measures:

Satisfaction
Quality of life

Estimated Enrollment:	150
Study Start Date:	December 2002
Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signing an informed consent form
Having a diagnosis of hypertension for more than one year according to patients'records.
receiving at least one medication for hypertension
A reasonable understanding of Hebrew
An ambulatory state enabling regular visits to a primary physician in the community and self-measurement of hypertension using the electronic device

Exclusion Criteria:

Lack of willingness to participate in the study.Known arrhythmia
Malignant disease
Poor understanding of Hebrew

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459017

Locations

Israel
Kupat Holim Meuhedet
Tel Aviv, Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

Yasmin Maor, MD

Sheba Medical Center

More Information

No publications provided

Study ID Numbers:	SHEBA -02-2773-YM-CTIL
Study First Received:	April 10, 2007
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00459017 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

24 hour ambulatory blood pressure measurement
Mean blood pressure
Wrist manometer
Frequent measurement

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010