HypertensionherzlebenNCT00453037
Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients
A study testing structured educational program and participation in the educational program after 6 months in people with Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the effects of a structured educational program for hypertensive patients. The program was developed at the University of Dusseldorf, Germany. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- structured educational program and participation in the educational program after 6 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intellectual and physical ability to attend teaching program,
- Capability to do and document blood pressure self-measurement,
- Systolic blood pressure >160 and/or diastolic blood pressure >95 mmHg,
- At least 3 months of preexisting medicamentous anti-hypertensive treatment,
- 15% or higher risc in New Zealand Risc Scale
Who cannot join
- Failing inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients and Effects of a Reminder Program for Physicians to Guide Optimal Therapy
The purpose of this study is to evaluate the effects of a structured educational program for hypertensive patients. The program was developed at the University of Dusseldorf, Germany. The contents of the program are as follows: teaching of the background of hypertension, techniques of self estimation of blood pressure, life style and dietary habits, some information concerning the different pharmacological properties to treat hypertension
Read the detailed description
see brief description section
- Conditions
- Hypertension
- Being tested
- structured educational program, participation in the educational program after 6 months
- Keywords
- hypertension, self measurement of blood pressure, education program, life style
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured educational programBehavioural
Also called educational program at time of inclusion, delayed educational program six moth later
structured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program
participation in the educational program after 6 monthsBehavioural
Control group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group
| Study group | Role | What they receive |
|---|---|---|
| group I (early intervention) | Active comparator | We refer to the results of the DAFNE-study. This study showed the merits of an educational program in diabetics. In accordance to the protocol of DAFNE, we developed a design as follows: For each participating center patients are randomly assigned to two groups. Group I receives an early educational intervention at time of randomization, which should lead to better control of blood pressure after 6 months compared to the control group. The protocol design was chosen for proving an independent effect of the educational program despite optimal management by the GP. Group II is designated to receive the educational intervention 6 months after enrollment into the study.
for further details please see brief description section Receives: Behavioral: structured educational program |
| delayed education | Other | delayed educational intervention
for further details please see brief description section Receives: Behavioral: participation in the educational program after 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure at 6 and 12 months of follow up following the educational process
Measured: 1 year
Secondary outcomes (1)
morbidity on different cardiovascular and cerebrovascular diseases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Robert Zweiker, MD AssocProf, Principal investigator, Medical University Graz Dep of Internal Medicine; Div of CardiologyThomas R Pieber, MD AssocProf, Principal investigator, Medical University Graz Dept of Internal Medicine Div of Diabetology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453037
- Sponsor's protocol ID
- 17019ex05-06
- Acronym
- herzleben
- Status last verified
- Jan 2011
- First submitted
- 27 Mar 2007
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Perl S, Niederl E, Kos C, Mrak P, Ederer H, Rakovac I, Beck P, Kraler E, Stoff I, Klima G, Pieske BM, Pieber TR, Zweiker R. Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension. Am J Hypertens. 2016 Jul;29(7):866-72. doi: 10.1093/ajh/hpv186. Epub 2015 Dec 7.
PubMed 26643687
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients and Effects of a Reminder Program for Physicians to Guide Optimal Therapy
- ClinicalTrials.gov ID
- NCT00453037
- Acronym / sponsor ID
- herzleben / 17019ex05-06
- Conditions
- Hypertension
- Keywords
- hypertension, self measurement of blood pressure, education program, life style
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of a structured educational program for hypertensive patients. The program was developed at the University of Dusseldorf, Germany. The contents of the program are as follows: teaching of the background of hypertension, techniques of self estimation of blood pressure, life style and dietary habits, some information concerning the different pharmacological properties to treat hypertension
Detailed description
see brief description section
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I (early intervention) | Active comparator | Behavioral: structured educational programWe refer to the results of the DAFNE-study. This study showed the merits of an educational program in diabetics. In accordance to the protocol of DAFNE, we developed a design as follows: For each participating center patients are randomly assigned to two groups. Group I receives an early educational intervention at time of randomization, which should lead to better control of blood pressure after 6 months compared to the control group. The protocol design was chosen for proving an independent effect of the educational program despite optimal management by the GP. Group II is designated to receive the educational intervention 6 months after enrollment into the study. for further details please see brief description section |
| delayed education | Other | Behavioral: participation in the educational program after 6 monthsdelayed educational intervention for further details please see brief description section |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intellectual and physical ability to attend teaching program,
- Capability to do and document blood pressure self-measurement,
- Systolic blood pressure >160 and/or diastolic blood pressure >95 mmHg,
- At least 3 months of preexisting medicamentous anti-hypertensive treatment,
- 15% or higher risc in New Zealand Risc Scale
Key exclusion criteria (1 listed)
- Failing inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured educational programAlso: educational program at time of inclusion, delayed educational program six moth laterstructured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program | Behavioural | group I (early intervention) |
| participation in the educational program after 6 monthsControl group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group | Behavioural | delayed education |
Primary outcome
Blood pressure at 6 and 12 months of follow up following the educational process
Time frame: 1 year
1 secondary outcome
morbidity on different cardiovascular and cerebrovascular diseases
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
- Derived from this study: PubMed 26643687Perl S, Niederl E, Kos C, Mrak P, Ederer H, Rakovac I, Beck P, Kraler E, Stoff I, Klima G, Pieske BM, Pieber TR, Zweiker R. Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension. Am J Hypertens. 2016 Jul;29(7):866-72. doi: 10.1093/ajh/hpv186. Epub 2015 Dec 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zweiker, MD AssocProf principal investigator
Medical University Graz Dep of Internal Medicine; Div of Cardiology
Thomas R Pieber, MD AssocProf principal investigator
Medical University Graz Dept of Internal Medicine Div of Diabetology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured educational program and participation in the educational program after 6 months in people with Hypertension, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure at 6 and 12 months of follow up following the educational process (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.