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

NCT ID: NCT00453037

Last Updated: 2011-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-12-31

Brief Summary

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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

Detailed Description

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see brief description section

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

structured educational program

Intervention Type BEHAVIORAL

structured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program

delayed education

delayed educational intervention

for further details please see brief description section

Group Type OTHER

participation in the educational program after 6 months

Intervention Type BEHAVIORAL

Control group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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educational program at time of inclusion delayed educational program six moth later

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Dept of Cardiology

Principal Investigators

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Robert Zweiker, MD AssocProf

Role: PRINCIPAL_INVESTIGATOR

Medical University Graz Dep of Internal Medicine; Div of Cardiology

Thomas R Pieber, MD AssocProf

Role: PRINCIPAL_INVESTIGATOR

Medical University Graz Dept of Internal Medicine Div of Diabetology

Locations

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Medical University Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

References

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Perl S, Niederl E, Kos C, Mrak P, Ederer H, Rakovac I, Beck P, Kraler E, Stoff I, Klima G, Pieske BM, Pieber TR, Zweiker R. Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension. Am J Hypertens. 2016 Jul;29(7):866-72. doi: 10.1093/ajh/hpv186. Epub 2015 Dec 7.

Reference Type DERIVED
PMID: 26643687 (View on PubMed)

Other Identifiers

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17019ex05-06

Identifier Type: -

Identifier Source: org_study_id

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