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A Comparison of Telemedical and Conventional Antihypertensive Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282334
First Posted: January 26, 2006
Last Update Posted: August 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
  Purpose

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 Intervention Phase
Hypertension Device: Telemedical blood pressure monitoring Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Telemedical and Conventional Antihypertensive Treatment

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • 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


Enrollment: 236
Study Start Date: May 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: January 24, 2006
First Posted: January 26, 2006
Results First Submitted: February 18, 2010
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