Validation of a Hypertension Education Program

Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676414
• Other study ID #: DHL-HEP1
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 5, 2016
• Start date: August 2015

Study information

• Verified date: February 2016
• Source: Charite University, Berlin, Germany
• Contact: Reinhold Kreutz, Professor
• Email: reinhold.kreutz[@]charite.de
• Is FDA regulated: No
• Health authority: Ethics Committee of the Medical Faculty, Ruhr University: Germany
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Behavioral:
• Interactive hypertension education program of the DHL©

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum Ruhr-Universität Bochum	Bad Oeynhausen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Office systolic blood pressure (mmHg)		6 months	No
Secondary	Office diastolic blood pressure (mmHg)		6 months	No
Secondary	Self-measured systolic and diastolic blood pressure (mmHg)		6 months	No
Secondary	24-hour ambulatory blood pressure monitoring (mmHg)		6 months	No
Secondary	Body Mass Index (kg per m2)		6 months	No
Secondary	Physical activity (hours per week)		6 months	No
Secondary	Alcohol consumption (drinks per week)		6 months	No
Secondary	Quality of life based on the Quality of Life Questionnaire "The Short Form 36 Health Survey"		6 months	No
Secondary	Knowledge regarding arterial hypertension based on the DHL© Questionnaire		6 months	No