NCT02676414

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 4, 2016

Last Update Submit

February 5, 2016

Conditions

Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Office systolic blood pressure (mmHg)

    6 months

Secondary Outcomes (8)

  • Office diastolic blood pressure (mmHg)

    6 months

  • Self-measured systolic and diastolic blood pressure (mmHg)

    6 months

  • 24-hour ambulatory blood pressure monitoring (mmHg)

    6 months

  • Body Mass Index (kg per m2)

    6 months

  • Physical activity (hours per week)

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Education program

OTHER

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©

Controls

NO INTERVENTION

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

Interventions

Interactive hypertension education program of the DHL©BEHAVIORAL
Education program

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz- und Diabeteszentrum Ruhr-Universität Bochum

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Reinhold Kreutz, Professor

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinhold Kreutz, Professor

CONTACT

reinhold.kreutz@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 8, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

DE(1)