Validation of a Hypertension Education Program

February 5, 2016 updated by: Reinhold Kreutz, Charite University, Berlin, Germany

Validation of the Hypertension Education Program of the German Hypertension League (DHL©) "My Blood Pressure - OK!"

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum Ruhr-Universität Bochum
        • Contact:
          • Siegfried Eckert, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Education program
Group of patients participating in the interactive hypertension education program of the DHL© "My blood pressure - OK!"
Behavioral: Interactive hypertension education program of the DHL©
No Intervention: Controls
Group of patients not participating in the interactive hypertension education program of the DHL© "My blood pressure - OK!" ("usual care")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Office systolic blood pressure (mmHg)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Office diastolic blood pressure (mmHg)
Time Frame: 6 months
6 months
Self-measured systolic and diastolic blood pressure (mmHg)
Time Frame: 6 months
6 months
24-hour ambulatory blood pressure monitoring (mmHg)
Time Frame: 6 months
6 months
Body Mass Index (kg per m2)
Time Frame: 6 months
6 months
Physical activity (hours per week)
Time Frame: 6 months
6 months
Alcohol consumption (drinks per week)
Time Frame: 6 months
6 months
Quality of life based on the Quality of Life Questionnaire "The Short Form 36 Health Survey"
Time Frame: 6 months
6 months
Knowledge regarding arterial hypertension based on the DHL© Questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Reinhold Kreutz, Professor, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHL-HEP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arterial Hypertension

Clinical Trials on Interactive hypertension education program of the DHL©

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe