HypertensionPhase 3NCT00459017
The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension
A Phase 3 study testing Portable blood pressure wrist manometer in people with Hypertension, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Portable blood pressure wrist manometer
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2002to Jun 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of willingness to participate in the study.Known arrhythmia
- Malignant disease
- Poor understanding of Hebrew
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypertension
- Being tested
- Portable blood pressure wrist manometer
- Keywords
- 24 hour ambulatory blood pressure measurement, Mean blood pressure, Wrist manometer, Frequent measurement
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable blood pressure wrist manometerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Meam blood pressure
Secondary outcomes (2)
Satisfaction
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startDec 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Yasmin Maor, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459017
- Sponsor's protocol ID
- SHEBA -02-2773-YM-CTIL
- Status last verified
- Apr 2007
- First submitted
- 10 Apr 2007
- Last updated
- 11 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension
- ClinicalTrials.gov ID
- NCT00459017
- Acronym / sponsor ID
- SHEBA -02-2773-YM-CTIL
- Conditions
- Hypertension
- Keywords
- 24 hour ambulatory blood pressure measurement, Mean blood pressure, Wrist manometer, Frequent measurement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2002
- Study completion
- Jun 2005 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Lack of willingness to participate in the study.Known arrhythmia
- Malignant disease
- Poor understanding of Hebrew
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable blood pressure wrist manometer | Device | – |
Primary outcome
Meam blood pressure
2 secondary outcomes
Satisfaction
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Maor, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Portable blood pressure wrist manometer in people with Hypertension, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meam blood pressure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2007.