NCT00459017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Dec 2002

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

April 10, 2007

Last Update Submit

April 10, 2007

Conditions

Keywords

24 hour ambulatory blood pressure measurementMean blood pressureWrist manometerFrequent measurement

Outcome Measures

Primary Outcomes (1)

  • Meam blood pressure

Secondary Outcomes (2)

  • Satisfaction

  • Quality of life

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kupat Holim Meuhedet

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Yasmin Maor, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

December 1, 2002

Study Completion

June 1, 2005

Last Updated

April 11, 2007

Record last verified: 2007-04

Locations