Implementation of shared decision-making by physician training to optimise hypertension treatment in Southern Baden.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00000125
• Date of registration: 02/06/2009
• Prospective Registration: Yes
• 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
• URL: http://drks.de/search/en/trial/DRKS00000125
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: health services research

Countries of recruitment

Germany

Contacts

• Name: Wilhelm Niebling
• Affiliation: Universitätsklinikum Freiburg, Lehrbereich Allgemeinmedizin

• Name: Iris Tinsel
• 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: None
Gender: All

Health Condition(s) or Problem(s) studied

Essential (primary) hypertension

I10
I11
I12
I13
I15

Hypertensive heart and renal disease

Hypertensive heart disease

Hypertensive renal disease

Secondary hypertension

Intervention(s)

Group 1: Treatment after specific physician training to implement Share Decision Making
Group 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

Source(s) of Monetary Support

BMBF: Bundesministerium für Bildung und Forschung, Dienstsitz Berlin:

Ethics review

Status: Approved
Approval date: 26/02/2009
Contact:

[e-mail]

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

[phone]

[e-mail]

Results

• Date Completed: 27/09/2011
• URL: http://drks.de/search/en/trial/DRKS00000125#studyResults