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NCT00282334 Clinical Trial

A Comparison of Telemedical and Conventional Antihypertensive Treatment

Hypertension Clinical Trial

Official title:
A Comparison of Telemedical and Conventional Antihypertensive Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282334
Other study ID # MED.RES.2004.01.LBM
Secondary ID
Status Completed
Phase Phase 4
First received January 24, 2006
Last updated July 29, 2011
Start date May 2004
Est. completion date December 2008

Study information
Verified date July 2011
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 236
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Telemedical blood pressure monitoring
Measurement of home blood pressure, three times per week for three months and once a week for three months.

Locations
Country Name City State
Denmark Dept. of Medical Research, Holstebro Hospital Holstebro

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in Number of Patients Who Reached Target Blood Pressure 6 months No
Primary 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 No
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