NCT00453037

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 17, 2011

Status Verified

January 1, 2011

Enrollment Period

3.3 years

First QC Date

March 27, 2007

Last Update Submit

January 14, 2011

Conditions

Hypertension

Keywords

hypertensionself measurement of blood pressureeducation programlife style

Outcome Measures

Primary Outcomes (1)

  • Blood pressure at 6 and 12 months of follow up following the educational process

    1 year

Secondary Outcomes (1)

  • morbidity on different cardiovascular and cerebrovascular diseases

    1 year

Study Arms (2)

group I (early intervention)

ACTIVE COMPARATOR

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

delayed education

OTHER

delayed educational intervention for further details please see brief description section

Behavioral: participation in the educational program after 6 months

Interventions

structured educational programBEHAVIORAL

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

Also known as: educational program at time of inclusion, delayed educational program six moth later
group I (early intervention)
participation in the educational program after 6 monthsBEHAVIORAL

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

delayed education

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • % or higher risc in New Zealand Risc Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, A-8036, Austria

Location

Related Publications (1)

  • 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.

    PMID: 26643687DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 28, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

January 17, 2011

Record last verified: 2011-01

Locations

AU(1)