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A Comparison of Telemedical and Conventional Antihypertensive Treatment

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ClinicalTrials.gov Identifier: NCT00282334
Recruitment Status : Completed
First Posted : January 26, 2006
Results First Posted : July 29, 2011
Last Update Posted : August 1, 2011
Sponsor:
Information provided by:
Regional Hospital Holstebro

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Hypertension Device: Telemedical blood pressure monitoring Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Telemedical and Conventional Antihypertensive Treatment
Study Start Date : May 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Home blood pressure telemonitoring Device: Telemedical blood pressure monitoring
Measurement of home blood pressure, three times per week for three months and once a week for three months.
No Intervention: Conventional blood pressure monitoring



Primary Outcome Measures :
  1. Difference in Number of Patients Who Reached Target Blood Pressure [ Time Frame: 6 months ]
  2. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282334


Locations
Denmark
Dept. of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Line B Madsen, MD Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark
Study Chair: Erling B Pedersen, Professor Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erling Bjerregaard Pedersen, Dept. of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT00282334     History of Changes
Other Study ID Numbers: MED.RES.2004.01.LBM
First Posted: January 26, 2006    Key Record Dates
Results First Posted: July 29, 2011
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by Regional Hospital Holstebro:
Telemedicine
Blood pressure
Quality of life
Cost-effectiveness

Additional relevant MeSH terms:
Antihypertensive Agents