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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

Tracking Information
First Submitted Date  ICMJE January 24, 2006
First Posted Date  ICMJE January 26, 2006
Results First Submitted Date  ICMJE February 18, 2010
Results First Posted Date  ICMJE July 29, 2011
Last Update Posted Date August 1, 2011
Study Start Date  ICMJE May 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Telemedical and Conventional Antihypertensive Treatment
Official Title  ICMJE A Comparison of Telemedical and Conventional Antihypertensive Treatment
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Device: Telemedical blood pressure monitoring
Measurement of home blood pressure, three times per week for three months and once a week for three months.
Study Arms  ICMJE
  • Experimental: Home blood pressure telemonitoring
    Intervention: Device: Telemedical blood pressure monitoring
  • No Intervention: Conventional blood pressure monitoring
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2011)
236
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282334
Other Study ID Numbers  ICMJE MED.RES.2004.01.LBM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erling Bjerregaard Pedersen, Dept. of Medical Research, Holstebro Hospital
Study Sponsor  ICMJE Regional Hospital Holstebro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Regional Hospital Holstebro
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP