Comparison of Telemedical and Conventional Treatment of Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Telemedical home blood pressure measurements; Behavioral: Conventional blood pressure monitoring

• Registration Number: NCT02531347
• Lead Sponsor: Erling Bjerregaard Pedersen

Brief Summary

The purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements.

Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-21
• Last Update Submitted: 2015-08-21
• Study First Posted: 2015-08-24
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Age 55 to 64 years
• Registered address in the Municipality of Holstebro
• Enrolment at a practice of one of the general practitioners who had agreed to participate in the study
• Telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3.
• Elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
• Hypertension confirmed by daytime ambulatory blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
• ECG verified sinus rhythm

Exclusion Criteria

• Unwillingness to participate
• Normotension
• Withdrawal of consent to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedical blood pressure monitoring	Telemedical home blood pressure measurements	Telemedical home blood pressure measurements for three days every second week. The average of all measures excluding day one is electronically transmitted to the General Practitioners. Following communication primarily by email or telephone.
Conventional blood pressure monitoring	Conventional blood pressure monitoring	Conventional blood pressure monitoring

Primary Outcome Measures

Name	Time	Method
Blood pressure reduction	3 month	Difference in daytime ambulatory blood pressure from baseline to followup between intervention and control group

Secondary Outcome Measures

Name	Time	Method
Number of patients reaching target blood pressure	3 month