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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.
Register: German Clinical Trials Register
Last refreshed on: 29 June 2014
Main ID:  DRKS00000125
Date of registration: 02/06/2009
Primary sponsor: Medizinische Universitätsklinik Freiburg, Abteilung Innere Medizin IV, Schwerpunkt Nephrologie und Allgemeinmedizin
Public title: Implementation of shared decision-making by physician training to optimise hypertension treatment in Southern Baden.
Scientific title: Implementation of shared decision-making by physician training to optimise hypertension treatment in Southern Baden. - BBB
Date of first enrolment: 05/06/2009
Target sample size: 1800
Recruitment status: Complete: follow-up complete
URL:  http://www.drks.de/DRKS00000125
Study type:  interventional
Study design:  Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject). Control: Active control. Assignment: Parallel. Study design purpose: Health care system;  
Countries of recruitment
Germany
Contacts
Name: Wilhelm  Niebling
Address:  Elsässer Str. 2m 79110 Freiburg Germany
Telephone: 0049 - 761 - 270 - 72490
Email: wilhelm.niebling@uniklinik-freiburg.de
Affiliation:  Universitätsklinikum Freiburg, Lehrbereich Allgemeinmedizin
Name: Iris  Tinsel
Address:  Elsässerstr. 2m 79110 Freiburg Germany
Telephone: 0049-761-270-77920
Email: iris.tinsel@uniklinik-freiburg.de
Affiliation:  Universitätsklinikum Freiburg, Medizinische Fakultät, Lehrbereich Allgemeinmedizin, Schwerpunkt Forschung
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
I10 - Essential (primary) hypertension
I11 - Hypertensive heart disease
I12 - Hypertensive renal disease
I13 - Hypertensive heart and renal disease
I15 - Secondary hypertension
Intervention(s)
Intervention 1: Treatment after specific physician training to implement Share Decision Making Intervention 2: Treatment As Usual
Primary Outcome(s)
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
Secondary Outcome(s)
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
Secondary ID(s)
61/09
Source(s) of Monetary Support
BMBF: Bundesministerium für Bildung und Forschung, Dienstsitz Berlin:
Secondary Sponsor(s)
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