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

M

Medical University of Graz

Status

Completed

Conditions

Hypertension

Treatments

Behavioral: structured educational program
Behavioral: participation in the educational program after 6 months

Study type

Interventional

Funder types

Other

Identifiers

NCT00453037
17019ex05-06

Details and patient eligibility

About

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

Full description

see brief description section

Enrollment

256 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

256 participants in 2 patient groups

group I (early intervention)
Active Comparator group
Description:
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
Treatment:
Behavioral: structured educational program
delayed education
Other group
Description:
delayed educational intervention for further details please see brief description section
Treatment:
Behavioral: participation in the educational program after 6 months

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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