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A Comparison of Telemedical and Conventional Antihypertensive Treatment

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00282334
First received: January 24, 2006
Last updated: July 29, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Regional Hospital Holstebro

Additional 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
Study First Received: January 24, 2006
Results First Received: February 18, 2010
Last Updated: July 29, 2011
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014