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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00453037
Other study ID # 17019ex05-06
Secondary ID
Status Completed
Phase N/A
First received March 27, 2007
Last updated January 14, 2011
Start date March 2007
Est. completion date December 2010

Study information

Verified date January 2011
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

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


Description:

see brief description section


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date December 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Austria Medical University Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure at 6 and 12 months of follow up following the educational process 1 year No
Secondary morbidity on different cardiovascular and cerebrovascular diseases 1 year No
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