HypertensionPhase 4NCT00282334

A Comparison of Telemedical and Conventional Antihypertensive Treatment

A Phase 4 study testing Telemedical blood pressure monitoring in people with Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to compare telemedical antihypertensive treatment based on home blood pressure monitoring and conventional antihypertensive treatment based on monitoring of blood pressure in the doctor's office. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension
What is being tested?: Telemedical blood pressure monitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 1 siteDenmark
Study dates: May 2004to Dec 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 20 - 80 years
office blood pressure > 150/95 mmHg or systolic blood pressure >150 mmHg and diastolic blood pressure < 90 mmHg

Who cannot join

not able to perform home blood pressure measurements
low compliance
abuse of alcohol/ medicine
unwillingness to participate

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Dept. of Medical Research, Holstebro Hospital
Holstebro, 7500

Other trials in Denmark

About this study

We want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective.

Conditions: Hypertension
Being tested: Telemedical blood pressure monitoring
Keywords: Telemedicine, Blood pressure, Quality of life, Cost-effectiveness
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telemedical blood pressure monitoringDevice
Measurement of home blood pressure, three times per week for three months and once a week for three months.

Study groups in NCT00282334
Study group	Role	What they receive
Home blood pressure telemonitoring	Experimental	Not described Receives: Device: Telemedical blood pressure monitoring
Conventional blood pressure monitoring	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Number of Patients Who Reached Target Blood Pressure
Measured: 6 months
Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months
Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups
Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2004Dec 2008

First posted26 Jan 2006 (estimated)
Study startMay 2004
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00282334
Sponsor's protocol ID: MED.RES.2004.01.LBM
Status last verified: Jul 2011
First submitted: 24 Jan 2006
Last updated: 1 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Madsen LB, Christiansen T, Kirkegaard P, Pedersen EB. Economic evaluation of home blood pressure telemonitoring: a randomized controlled trial. Blood Press. 2011 Apr;20(2):117-25. doi: 10.3109/08037051.2010.532306. Epub 2010 Nov 24.
PubMed 21105759

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Telemedical and Conventional Antihypertensive Treatment
ClinicalTrials.gov ID: NCT00282334
Acronym / sponsor ID: MED.RES.2004.01.LBM
Conditions: Hypertension
Keywords: Telemedicine, Blood pressure, Quality of life, Cost-effectiveness
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Regional Hospital HolstebroUniversity, hospital or other
Study start: May 2004
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 26 Jan 2006 (estimated)
Results: Posted 29 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

We want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Home blood pressure telemonitoring	Experimental	Device: Telemedical blood pressure monitoring
Conventional blood pressure monitoring	No intervention	–

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

age 20 - 80 years
office blood pressure > 150/95 mmHg or systolic blood pressure >150 mmHg and diastolic blood pressure < 90 mmHg

Key exclusion criteria (4 listed)

not able to perform home blood pressure measurements
low compliance
abuse of alcohol/ medicine
unwillingness 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 blood pressure monitoringMeasurement of home blood pressure, three times per week for three months and once a week for three months.	Device	Home blood pressure telemonitoring

Primary outcome

Difference in Number of Patients Who Reached Target Blood Pressure
Time frame: 6 months
Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months
Time frame: baseline and 6 months
Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups

Results and safety

Results posted to the registry on 29 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telemonitoring	113	105
Conventional	123	118

Primary outcome: Difference in Number of Patients Who Reached Target Blood Pressure

Time frame: 6 months. Number. Unit: participants

The sponsor has not posted figures for this outcome.

Primary outcome: Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months

Time frame: baseline and 6 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Conventional Blood Pressure Monitoring n = 123	Telemonitoring of Home Blood Press n = 113
Value	-11.9 (14.8)	-9.6 (14.7)

Population analysed: Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Blood Pressure Monitoring	0 of 123 (0%)	0 of 123 (0%)	Not reported
Telemonitoring of Home Blood Press	0 of 113 (0%)	0 of 113 (0%)	Not reported

Limitations and caveats (from the sponsor): Technical difficulties with telemedical equipment,referral bias,unblinded study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21105759Madsen LB, Christiansen T, Kirkegaard P, Pedersen EB. Economic evaluation of home blood pressure telemonitoring: a randomized controlled trial. Blood Press. 2011 Apr;20(2):117-25. doi: 10.3109/08037051.2010.532306. Epub 2010 Nov 24.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Line B Madsen, MD principal investigator

Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark

Erling B Pedersen, Professor study chair

Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telemedical blood pressure monitoring in people with Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.

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 2 inclusion and 4 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 1 Aug 2011. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in Number of Patients Who Reached Target Blood Pressure (time frame: 6 months). 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 NCT00282334, 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 1 Aug 2011.