Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients (herzleben)

January 14, 2011 updated by: Medical University of Graz

Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients and Effects of a Reminder Program for Physicians to Guide Optimal Therapy

The purpose of this study is to evaluate the effects of a structured educational program for hypertensive patients. The program was developed at the University of Dusseldorf, Germany. The contents of the program are as follows: teaching of the background of hypertension, techniques of self estimation of blood pressure, life style and dietary habits, some information concerning the different pharmacological properties to treat hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see brief description section

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, A-8036
        • Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intellectual and physical ability to attend teaching program,
  • Capability to do and document blood pressure self-measurement,
  • Systolic blood pressure >160 and/or diastolic blood pressure >95 mmHg,
  • At least 3 months of preexisting medicamentous anti-hypertensive treatment,
  • 15% or higher risc in New Zealand Risc Scale

Exclusion Criteria:

  • Failing inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I (early intervention)

We refer to the results of the DAFNE-study. This study showed the merits of an educational program in diabetics. In accordance to the protocol of DAFNE, we developed a design as follows: For each participating center patients are randomly assigned to two groups. Group I receives an early educational intervention at time of randomization, which should lead to better control of blood pressure after 6 months compared to the control group. The protocol design was chosen for proving an independent effect of the educational program despite optimal management by the GP. Group II is designated to receive the educational intervention 6 months after enrollment into the study.

for further details please see brief description section
Behavioral: structured educational program
structured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program
Other Names:
  • educational program at time of inclusion
  • delayed educational program six moth later
Other: delayed education

delayed educational intervention

for further details please see brief description section
Behavioral: participation in the educational program after 6 months
Control group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure at 6 and 12 months of follow up following the educational process
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
morbidity on different cardiovascular and cerebrovascular diseases
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Robert Zweiker, MD AssocProf, Medical University Graz Dep of Internal Medicine; Div of Cardiology
  • Principal Investigator: Thomas R Pieber, MD AssocProf, Medical University Graz Dept of Internal Medicine Div of Diabetology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17019ex05-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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