Comparison of Telemedical and Conventional Treatment of Hypertension
Treatment of Hypertension Using Telemedical Home Blood Pressure Measurements
1 other identifier
interventional
375
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Mar 2011
Longer than P75 for not_applicable hypertension
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
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedAugust 24, 2015
August 1, 2015
3.8 years
August 20, 2015
August 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Blood pressure reduction
Difference in daytime ambulatory blood pressure from baseline to followup between intervention and control group
3 month
Secondary Outcomes (1)
Number of patients reaching target blood pressure
3 month
Study Arms (2)
Telemedical blood pressure monitoring
EXPERIMENTALTelemedical 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
ACTIVE COMPARATORConventional blood pressure monitoring
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unwillingness to participate
- Normotension
- Withdrawal of consent to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. J Hum Hypertens. 2017 Feb;31(2):93-98. doi: 10.1038/jhh.2016.43. Epub 2016 Jun 23.
PMID: 27334521DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikolai Hoffmann-Petersen, MD
Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Chief Physician
Study Record Dates
First Submitted
August 20, 2015
First Posted
August 24, 2015
Study Start
March 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 24, 2015
Record last verified: 2015-08