Comparison of Telemedical and Conventional Treatment of Hypertension

NCT ID: NCT02531347

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telemedical blood pressure monitoring

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.

Group Type EXPERIMENTAL

Telemedical home blood pressure measurements

Intervention Type BEHAVIORAL

Conventional blood pressure monitoring

Conventional blood pressure monitoring

Group Type ACTIVE_COMPARATOR

Conventional blood pressure monitoring

Intervention Type BEHAVIORAL

Interventions

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Telemedical home blood pressure measurements

Intervention Type BEHAVIORAL

Conventional blood pressure monitoring

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erling Bjerregaard Pedersen

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

Professor, Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nikolai Hoffmann-Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark

References

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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.

Reference Type DERIVED
PMID: 27334521 (View on PubMed)

Other Identifiers

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M-20110013

Identifier Type: -

Identifier Source: org_study_id

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