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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00459017
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : April 11, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Device: Portable blood pressure wrist manometer Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension
Study Start Date : December 2002
Study Completion Date : June 2005
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Meam blood pressure

Secondary Outcome Measures :
  1. Satisfaction
  2. Quality of life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00459017     History of Changes
Other Study ID Numbers: SHEBA -02-2773-YM-CTIL
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007

Keywords provided by Sheba Medical Center:
24 hour ambulatory blood pressure measurement
Mean blood pressure
Wrist manometer
Frequent measurement

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases