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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00459017
First received: April 10, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00459017     History of Changes
Other Study ID Numbers: SHEBA -02-2773-YM-CTIL
Study First Received: April 10, 2007
Last Updated: April 10, 2007
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013