HypertensionNCT02531347
Comparison of Telemedical and Conventional Treatment of Hypertension
A study testing Telemedical home blood pressure measurements and Conventional blood pressure monitoring in people with Hypertension, run by Erling Bjerregaard Pedersen.
Trial summary
The purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements. Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better… 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 and Conventional blood pressure monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2014
- Phase
- Interventional
- 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
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 general practitioners who had agreed to participate in the study
- Telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3.
- Elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
- Hypertension confirmed by daytime ambulatory blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
- ECG verified sinus rhythm
Who cannot join
- Unwillingness to participate
- Normotension
- Withdrawal of consent to participate
About this study
Official title: Treatment of Hypertension Using Telemedical Home Blood Pressure Measurements
The purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements.
Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.
- Conditions
- Hypertension
- Being tested
- Telemedical home blood pressure measurements, Conventional blood pressure monitoring
- 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 measurementsBehavioural
Conventional blood pressure monitoringBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Telemedical blood pressure monitoring | Experimental | Telemedical home blood pressure measurements for three days every second week. The average of all measures excluding day one is electronically transmitted to the General Practitioners. Following communication primarily by email or telephone. Receives: Behavioral: Telemedical home blood pressure measurements |
| Conventional blood pressure monitoring | Active comparator | Conventional blood pressure monitoring Receives: Behavioral: Conventional blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
Difference in daytime ambulatory blood pressure from baseline to followup between intervention and control group
Measured: 3 month
Secondary outcomes (1)
Number of patients reaching target blood pressure
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 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
- NCT02531347
- Sponsor's protocol ID
- M-20110013
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. J Hum Hypertens. 2017 Feb;31(2):93-98. doi: 10.1038/jhh.2016.43. Epub 2016 Jun 23.
PubMed 27334521
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypertension Using Telemedical Home Blood Pressure Measurements
- ClinicalTrials.gov ID
- NCT02531347
- Acronym / sponsor ID
- M-20110013
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Aug 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 the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements.
Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedical blood pressure monitoring | Experimental | Behavioral: Telemedical home blood pressure measurementsTelemedical home blood pressure measurements for three days every second week. The average of all measures excluding day one is electronically transmitted to the General Practitioners. Following communication primarily by email or telephone. |
| Conventional blood pressure monitoring | Active comparator | Behavioral: Conventional blood pressure monitoringConventional blood pressure monitoring |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 55 to 64 years
- Registered address in the Municipality of Holstebro
- Enrolment at a practice of one of the general practitioners who had agreed to participate in the study
- Telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3.
- Elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
Key exclusion criteria (3 listed)
- Unwillingness to participate
- Normotension
- Withdrawal of consent to participate
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 | Behavioural | Telemedical blood pressure monitoring |
| Conventional blood pressure monitoring | Behavioural | Conventional blood pressure monitoring |
Primary outcome
Blood pressure reduction
Time frame: 3 month
Difference in daytime ambulatory blood pressure from baseline to followup between intervention and control group
1 secondary outcome
Number of patients reaching target blood pressure
Time frame: 3 month
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 24 Aug 2015.
- Derived from this study: PubMed 27334521Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. J Hum Hypertens. 2017 Feb;31(2):93-98. doi: 10.1038/jhh.2016.43. Epub 2016 Jun 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?
A study testing Telemedical home blood pressure measurements and Conventional blood pressure monitoring in people with 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 7 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 24 Aug 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?
Blood pressure reduction (time frame: 3 month). 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 NCT02531347, 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 24 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.