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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
DRKS00000125 |
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Date of registration:
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02/06/2009 |
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Primary sponsor: |
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Public title:
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Implementation of shared decision-making by physician training to optimise hypertension treatment in Southern Baden.
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Scientific title:
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Implementation of shared decision-making by physician training to optimise hypertension treatment in Southern Baden. - BBB |
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Date of first enrolment:
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05/06/2009 |
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Target sample size:
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1800 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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http://www.drks.de/DRKS00000125 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled trial;. Masking: Single blind. Control: Active control. Assignment: Parallel. Study design purpose: Health care system;
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Countries of recruitment
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Germany
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Contacts
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Name:
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Wilhelm
Niebling |
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Address:
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Elsässer Str. 2m
79110
Freiburg
Germany |
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Telephone:
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0049 - 761 - 270 - 72490 |
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Email:
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wilhelm.niebling@uniklinik-freiburg.de |
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Affiliation:
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Universitätsklinikum Freiburg, Lehrbereich Allgemeinmedizin |
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Name:
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Karl-Georg
Fischer |
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Address:
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Hugstetter Straße 55
79106
Freiburg
Germany |
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Telephone:
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0049-761-270-32270 |
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Email:
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karl-georg.fischer@uniklinik-freiburg.de |
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Affiliation:
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Medizinische Universitätsklinik Freiburg, Abteilung Innere Medizin IV, Schwerpunkt Nephrologie und Allgemeinmedizin |
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Key inclusion & exclusion criteria
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Inclusion criteria: Repeated prescription for antihypertensive drugs.
Coverage by public health insurance (except Bundesknappschaft and Seekasse).
Exclusion criteria: Patient does not speak German. Patient suffers from dementia or is mentally handicapped. Patient with a serious progressive course of disease and short expectation of life.
Age minimum:
18 Years
Age maximum:
no maximum age
Gender:
Both, male and female
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Health Condition(s) or Problem(s) studied
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I10 - Essential (primary) hypertension
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I11 - Hypertensive heart disease
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I12 - Hypertensive renal disease
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I13 - Hypertensive heart and renal disease
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I15 - Secondary hypertension
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Intervention(s)
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Intervention 1: Treatment after specific physician training to implement Share Decision Making Intervention 2: Treatment As Usual
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Primary Outcome(s)
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Blood pressure optimization by patients with arterial hypertension by implementation of shared decision making.
(1) Change of systolic blood pressure (mean of 24-h-measurement) from baseline
(2) Change of patients' perceived participation (SDM-Q-9) from baseline
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Secondary Outcome(s)
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Change of
(1) diastolic blood pressure (mean of 24-h-measurement),
(2) adherence (MARS-D)
(3) patients' knowledge about arterial hypertension (own developemt) and
(4) cardiovascular 10-year-risk score (algorithm of the cardiovascular risk
calculator 'arriba')
from baseline
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Source(s) of Monetary Support
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BMBF: Bundesministerium für Bildung und Forschung,
Dienstsitz Berlin:
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