Hypertension Management in Primary Care: "Getting research into practice"
Organizational Data
- DRKS-ID:
- DRKS00006315
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2014-07-14
- Last update in DRKS:
- 2014-07-14
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Blood pressure control is important to decrease morbidity and mortality, e.g. due to myocardial infarction and stroke. Scientific studies showed that organizational interventions such as patient recall systems and the combination of non-pharmacological treatment with intensified medication increased blood pressure control and decreased mortality. This cluster randomized trial evaluates the effectiveness of a medical education series for primary care physicians about a modern hypertension management on blood pressure control in patients with high blood pressure.
Brief summary in scientific language
Evaluation of the effectiveness of a physician-centered medical education program about hypertension management on blood pressure control of hypertensive patients in primary care.
Health condition or problem studied
- ICD10:
- I10-I15 - Hypertensive diseases
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervention: Evidence-based three-part medical education program for general practitioners on hypertension management; core elements: 1) training on valid upper arm blood pressure readings, 2) evidence-based information on resistant hypertension, secondary hypertension, and modern pharmacotherapy, and 3) introduction and distribution of practice tools to facilitate the long-term implementation of hypertension management.
- Arm 2:
- Control: Physicians receive the intervention after completion of the follow-up data collection.
Endpoints
- Primary outcome:
- Blood pressure control rate measured by 24-hour blood pressure readings (blood pressure is measured before the intervention and three months after the last medical education session)
- Secondary outcome:
- Changes in average systolic and diastolic 24-hour blood pressure; implemented practice redesign elements such as patient recall systems, standardized sheets, disease-specific information leaflets, predefined practice procedures for hypertension management.
Study Design
- Purpose:
- Health care system
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice NRW
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-09-26
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- 179
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Hypertension according to international guidelines (office readings ≥140/90 mmHg, 24-hour ambulatory measurement ≥130/80 mmHg, and/or mean home measurements ≥135/85 mmHg based on a one week protocol with at least 2 measurements daily), with and without hypertension-related diseases
Exclusion Criteria
Unable to give informed consent, not able to read and comprehend the German language
Addresses
Primary Sponsor
- Address:
- Institut für Allgemeinmedizin, Universitätsklinikum Essen, Universität Duisburg-EssenProf. Dr. med. Stefan GesenhuesHufelandstraße 5545147 EssenGermany
- Telephone:
- 0201-877 869-0
- Fax:
- 0201-877-869-20
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Allgemeinmedizin, Universitätsklinikum Essen, Universität Duisburg-EssenPriv.-Doz. Dr. med. Birgitta Weltermann, MPH(USA)Hufelandstraße 5545147 EssenGermany
- Telephone:
- 0201-877 869-0
- Fax:
- 0201-877-869-20
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de
Contact for Public Queries
- Address:
- Institut für Allgemeinmedizin, Universitätsklinikum EssenPriv.-Doz. Dr. med. Birgitta Weltermann, MPH(USA)Hufelandstraße 5545147 EssenGermany
- Telephone:
- 0201-877-86910
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-essen.de
Principal Investigator
- Address:
- Institut für Allgemeinmedizin, Universitätsklinikum Essen, Universität Duisburg-EssenPriv.-Doz. Dr. med. Birgitta Weltermann, MPH(USA)Hufelandstraße 5545147 EssenGermany
- Telephone:
- 0201-877 869-0
- Fax:
- 0201-877-869-20
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministerium für Innovation, Wissenschaft und Forschung des Landes Nordrhein-Westfalen40221 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-EssenRobert-Koch-Str. 9-1145147 EssenGermany
- Telephone:
- +49-201-7233637
- Fax:
- +49-201-7235837
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-07-25
- Ethics committee number:
- 13-5537-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-09-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry