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Validation of a Hypertension Education Program

Primary Purpose

Arterial Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Interactive hypertension education program of the DHL©
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arterial Hypertension

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herz- und Diabeteszentrum Ruhr-Universität BochumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Education program

Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Office systolic blood pressure (mmHg)

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2016
Last Updated
February 5, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02676414
Brief Title
Validation of a Hypertension Education Program
Official Title
Validation of the Hypertension Education Program of the German Hypertension League (DHL©) "My Blood Pressure - OK!"
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education program
Arm Type
Other
Arm Description
Group of patients participating in the interactive hypertension education program of the DHL© "My blood pressure - OK!"
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Group of patients not participating in the interactive hypertension education program of the DHL© "My blood pressure - OK!" ("usual care")
Intervention Type
Behavioral
Intervention Name(s)
Interactive hypertension education program of the DHL©
Primary Outcome Measure Information:
Title
Office systolic blood pressure (mmHg)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Office diastolic blood pressure (mmHg)
Time Frame
6 months
Title
Self-measured systolic and diastolic blood pressure (mmHg)
Time Frame
6 months
Title
24-hour ambulatory blood pressure monitoring (mmHg)
Time Frame
6 months
Title
Body Mass Index (kg per m2)
Time Frame
6 months
Title
Physical activity (hours per week)
Time Frame
6 months
Title
Alcohol consumption (drinks per week)
Time Frame
6 months
Title
Quality of life based on the Quality of Life Questionnaire "The Short Form 36 Health Survey"
Time Frame
6 months
Title
Knowledge regarding arterial hypertension based on the DHL© Questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reinhold Kreutz, Professor
Email
reinhold.kreutz@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhold Kreutz, Professor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Diabeteszentrum Ruhr-Universität Bochum
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siegfried Eckert, MD

12. IPD Sharing Statement

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Validation of a Hypertension Education Program

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