Validation of a Hypertension Education Program

NCT ID: NCT02676414

Last Updated: 2016-02-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Brief Summary

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The primary purpose of this study is to assess the effect of participating in the interactive hypertension education program of the German Hypertension League (DHL©) "My blood pressure - OK!" on office systolic blood pressure.

Detailed Description

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Conditions

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Arterial 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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Education program

Group of patients participating in the interactive hypertension education program of the DHL© "My blood pressure - OK!"

Group Type OTHER

Interactive hypertension education program of the DHL©

Intervention Type BEHAVIORAL

Controls

Group of patients not participating in the interactive hypertension education program of the DHL© "My blood pressure - OK!" ("usual care")

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interactive hypertension education program of the DHL©

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \> 21 years of age
* Primary arterial hypertension
* Office blood pressure between 140/90 mmHg and 160/100 mmHg

Exclusion Criteria

* Participation in another clinical study
* Unstable clinical condition
* Secondary arterial hypertension
* Dementia
* Major disability (modified Rankin-Scale \> 4)
* Severe chronic kidney disease (serum creatinine \> 2.0 mg/dL or estimated glomerular filtration rate \< 40 ml/min/1.73m2)
* Liver disease including history of hepatic encephalopathy, esophageal varices or portacaval shunt
* History of gastrointestinal operation or disease with a potential influence on drug absorption
* Allergy or other contraindications against drugs given during the study
* History of non-compliance
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Reinhold Kreutz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reinhold Kreutz, Professor

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Herz- und Diabeteszentrum Ruhr-Universität Bochum

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Reinhold Kreutz, Professor

Role: CONTACT

Facility Contacts

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Siegfried Eckert, MD

Role: primary

Other Identifiers

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DHL-HEP1

Identifier Type: -

Identifier Source: org_study_id

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