A Comparison of Telemedical and Conventional Antihypertensive Treatment
1 other identifier
interventional
236
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started May 2004
Longer than P75 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
July 29, 2011
CompletedAugust 1, 2011
July 1, 2011
4.6 years
January 24, 2006
February 18, 2010
July 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in Number of Patients Who Reached Target Blood Pressure
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
baseline and 6 months
Study Arms (2)
Home blood pressure telemonitoring
EXPERIMENTALConventional blood pressure monitoring
NO INTERVENTIONInterventions
Measurement of home blood pressure, three times per week for three months and once a week for three months.
Eligibility Criteria
You may qualify if:
- age 20 - 80 years
- office blood pressure \> 150/95 mmHg or systolic blood pressure \>150 mmHg and diastolic blood pressure \< 90 mmHg
You may not qualify if:
- not able to perform home blood pressure measurements
- low compliance
- abuse of alcohol/ medicine
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Medical Research, Holstebro Hospital
Holstebro, 7500, Denmark
Related Publications (1)
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.
PMID: 21105759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Technical difficulties with telemedical equipment,referral bias,unblinded study
Results Point of Contact
- Title
- Line Bille Madsen
- Organization
- Dept. of Medical Research, Holstebro Hospital
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 26, 2006
Study Start
May 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 1, 2011
Results First Posted
July 29, 2011
Record last verified: 2011-07