Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00453037
First received: March 27, 2007
Last updated: January 14, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention
Hypertension
 Behavioral: structured educational program
Behavioral: participation in the educational program after 6 months

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Blood pressure at 6 and 12 months of follow up following the educational process [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morbidity on different cardiovascular and cerebrovascular diseases [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 256
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

see brief description section

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453037

Locations
Austria
Medical University Graz
Graz, Styria, Austria, A-8036
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Medical University of Graz, Dept of Cardiology
ClinicalTrials.gov Identifier: NCT00453037     History of Changes
Other Study ID Numbers: 17019ex05-06
Study First Received: March 27, 2007
Last Updated: January 14, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
hypertension
self measurement of blood pressure
education program
life style

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013