HypertensionNCT02355392
Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements
An observational study of Hypertension, run by Erling Bjerregaard Pedersen.
Trial summary
The purpose of this study is to determine the prevalence of hypertension among citizens of Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with… Read more about this study
- Who is it for?
- Ages 55 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Telemedical home blood pressure measurements
- How many people
- 3,159 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Oct 2014
- Phase
- Observational
- 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 55 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A population study in the municipality of Holstebro, which has 57.000 inhabitants. Using the Civil Registration System, we invite all citizens aged 55-64 years.
Who may be able to join
- Age 55 to 64 years
- Registered address in the municipality of Holstebro
- Enrolment at a practice of one of the GPs who had agreed to participate in the study.
Who cannot join
- Unwillingness to participate
- Incapability to do home blood pressure measurements
About this study
The purpose of this study is to determine the prevalence of hypertension among citizens of Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with telemedical data transmission.
- Conditions
- Hypertension
- Being tested
- Telemedical home blood pressure measurements
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedical home blood pressure measurementsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Office blood pressure
Measured: 10 minuttes
Telemedical home blood pressure
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Nikolai Hoffmann-Petersen, MD, Principal investigator, Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355392
- Sponsor's protocol ID
- M-20110011
- Status last verified
- Jan 2015
- First submitted
- 30 Jan 2015
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. High Prevalence of Hypertension in a Danish Population Telemedical Home Measurement of Blood Pressure in Citizens Aged 55-64 Years in Holstebro County. Am J Hypertens. 2016 Apr;29(4):439-47. doi: 10.1093/ajh/hpv116. Epub 2015 Jul 23.
PubMed 26208671
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements
- ClinicalTrials.gov ID
- NCT02355392
- Acronym / sponsor ID
- M-20110011
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,159 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Feb 2015 (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.
The purpose of this study is to determine the prevalence of hypertension among citizens of Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with telemedical data transmission.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A population study in the municipality of Holstebro, which has 57.000 inhabitants. Using the Civil Registration System, we invite all citizens aged 55-64 years.
Key inclusion criteria (3 listed)
- Age 55 to 64 years
- Registered address in the municipality of Holstebro
- Enrolment at a practice of one of the GPs who had agreed to participate in the study.
Key exclusion criteria (2 listed)
- Unwillingness to participate
- Incapability to do home blood pressure measurements
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 |
|---|---|---|
| Telemedical home blood pressure measurements | Other | – |
Primary outcome
Office blood pressure
Time frame: 10 minuttes
Telemedical home blood pressure
Time frame: 3 days
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 4 Feb 2015.
- Derived from this study: PubMed 26208671Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. High Prevalence of Hypertension in a Danish Population Telemedical Home Measurement of Blood Pressure in Citizens Aged 55-64 Years in Holstebro County. Am J Hypertens. 2016 Apr;29(4):439-47. doi: 10.1093/ajh/hpv116. Epub 2015 Jul 23.
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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.
Nikolai Hoffmann-Petersen, MD principal investigator
Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Erling Bjerregaard Pedersen.
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 3 inclusion and 2 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 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Office blood pressure (time frame: 10 minuttes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355392, which also lists 1 linked publication.
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 4 Feb 2015.