German Clinical Trials Register

Acronym/abbreviation of the study

BBB

URL of the study

No Entry

Brief summary in lay language

Arterial hypertension is a population-wide disease. Its secondary disorders significantly shorten the individual lifespan. The aim of the study is to find out if, and then to what extend blood pressure values of patients with arterial hypertension can be optimized by their active involvement in treatment decisions. In half of the study population, this shared decision making will be implemented by specific trainings of general practitioners and additional patient information. In the other half, general practitioners treat as usual. The physicians will be assigned to one of both groups by randomisation. The study aims to include patients in participating physician practices who are treated with antihypertensive medication and who are older then 18 years. Within the study, patient surveys and 24h blood pressure measurements will be performed. Additionally, prescription and dispense of antihypertensive medication, laboratory values and secondary diagnoses will be documented. The participation of patients with optimal long-term blood pressure values ends after this first 24h blood pressure measurement. Patients with non-optimal long-term blood pressure values remain in the study. During three study follow-ups with 6 month intervals patient surveys, 24h blood pressure measurements will be done. Again, prescription and dispense of antihypertensive medication, laboratory values and secondary diagnoses will be documented. Data protection: In this study personal data will be ascertained. During the data entry the data pertaining to research will be instantly separated from personal data and corresponding numbers will be attached (pseudonymisation). The data protection commissioner of the University Hospital Freiburg approved the procedure of data ascertainment, data processing and the data protection concept of the project. The data protection is guaranteed.

Brief summary in scientific language

Compared to other industrialized countries, prevalence of arterial hypertension in Germany is high. Optimal treatment relies on frequent and reliable intake of antihypertensive medication. However, only 26% of patients with arterial hypertension in Germany having been asked on this topic by a questionnaire upon study conditions state frequent intake of antihypertensive medication. Here, patients who are well informed about their disease and share treatment decisions show higher adherence. The study focuses on blood pressure optimization by active participation of patients in treatment decisions. We hypothesize that active participation of patients according to the principles of shared decision making (SDM) sustainably leads to advanced knowledge about the disease and an improved adherence translating into better blood pressure values and reduced cardiovascular morbidity and mortality. Within three months, approximately 1.800 patients with arterial hypertension are checked for their treatment results by long-term blood pressure measurements in the participating general practitioners practices. It is awaited that approximately 60% of patients (~1.200 pts.) do not reach treatment goals. These patients are cluster-randomized within the participating practices. In the intervention group, treatment is combined with structured SDM, whereas in the control group, treatment is continued without additional measures. Every 6 months compliance and knowledge of the patient are measured by standardized questionnaires and long-term blood pressure measurements are performed. Additionally, prescription and dispense of antihypertensive medication, laboratory values and secondary diagnoses will be documented. It is anticipated that SDM improves adherence, which subsequently leads to sustained blood pressure optimization resulting in reduced cardiovascular morbidity. Data protection: In this study personal data will be ascertained. During the data entry the data pertaining to research will be instantly separated from personal data and corresponding numbers will be attached (pseudonymisation). The data protection commissioner of the University Hospital Freiburg approved the procedure of data ascertainment, data processing and the data protection concept of the project. The data protection is guaranteed.