A Comparison of Telemedical and Conventional Antihypertensive Treatment

NCT ID: NCT00282334

Last Updated: 2011-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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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Home blood pressure telemonitoring

Group Type EXPERIMENTAL

Telemedical blood pressure monitoring

Intervention Type DEVICE

Measurement of home blood pressure, three times per week for three months and once a week for three months.

Conventional blood pressure monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemedical blood pressure monitoring

Measurement of home blood pressure, three times per week for three months and once a week for three months.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Medical Research, Holstebro Hospital

Principal Investigators

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Line B Madsen, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark

Erling B Pedersen, Professor

Role: STUDY_CHAIR

Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark

Locations

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Dept. of Medical Research, Holstebro Hospital

Holstebro, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 21105759 (View on PubMed)

Other Identifiers

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MED.RES.2004.01.LBM

Identifier Type: -

Identifier Source: org_study_id

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