Condition category
Circulatory System
Date applied
28/03/2017
Date assigned
05/04/2017
Last edited
28/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hypertension (high blood pressure) is a long term medical condition in which the pressure in the arteries is higher than it should be. It is major risk factor for cardiovascular disease (disease of the heart and blood vessels), which can lead to heart attack and stroke. Although there is a wide range of medications available that help lower blood pressure, many patient's still have poorly controlled blood pressure. In addition, for effective blood pressure control, many patients need to take more than one blood pressure medication. Having to take a lot of pills increases the risk that patients may not stick to their treatment program, leading to poor blood pressure control. The aim of this study is to complete a large-scale survey to investigate the motivation and key drivers in the therapeutic decision making process to improve (simplify or intensify) blood pressure medication treatment in patients with poorly controlled high blood pressure at general practitioners in Belgium and Luxembourg.

Who can participate?
Adults with high vlood pressure who are taking at least one blood pressure medication, are seen by a general practitioner in Belgium or Luxembourg.

What does the study involve?
Participants attend an appointment with their GP, who records information about their background, current medical treatment, and blood pressure. Based on this information the GP decides whether any changes are needed in the current medical treatment. The information is then collated in order to find out whether there are any patterns in a GPs decision to simplify or intensify blood pressure medication treatment.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those taking part in the study.

Where is the study run from?
Servier BeNeLux (Belgium)

When is the study starting and how long is it expected to run for?
January 2017 to September 2017

Who is funding the study?
Servier BeLux (Belgium)

Who is the main contact?
Mr Bregt Van Nieuwenhuyse

Trial website

Contact information

Type

Scientific

Primary contact

Mr Bregt Van Nieuwenhuyse

ORCID ID

Contact details

Servier Benelux
Internationalelaan 57
Anderlecht
1070
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VI 17/01/20/01

Study information

Scientific title

Cross-sectional survey evaluating the motivation and key drivers of general practitioners to SIMPLIFY or intensify antihypertensive treatment in the general uncontrolled hypertensive population treated with at least one antihypertensive agent in Belgium and Luxembourg

Acronym

SIMPLIFY

Study hypothesis

The aim of this study is to evaluate the motivation and key drivers of general practitioners to simplify or intensify antihypertensive treatment in uncontrolled hypertensive patients already treated with at least one antihypertensive drug.

Ethics approval

Due to the observational nature of this study, it does not require ethics approval according to the European directive and Belgian law. Nonetheless, the study has been approved by pharma.be (Bureau Des Visas Études Scientifiques Décision, 31/01/2017, ref: 17/01/20/01)

Study design

Cross-sectional observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension

Intervention

All participants attend an appointment to see their general practitioner, who is asked to record the following information:
1. Age, sex, weight and height of the patient
2. number of years previously being treated with antihypertensive drug(s)
3. Presence of comorbidities (specify: diabetes, renal insuffisciency, prior CV complications, heart failure, arritmia, renal insufficiency, dyslipidemia or other)
4. Systolic and diastolic blood pressure
5. compliance to antihypertensive treatment
6. Medical treatment before consultation /
6.1 need to change current medical treatment? (yes/no)
6.2 if 6.1 yes: Medical treatment after consultation
6. If the patient has been prescribed a single pill combination, for which reason? (better compliance, better prognosis, cheaper, better control of blood pressure, simpler for the patient?)

The information collected by the GP is data collected routinely by the GP during a standard consultation for hypertension. No other data than data needed for the patient file is collected. Based on the collected patient information and the performed medical decision making, it will be calculated which variables are the main drivers for simplification or intensification of the antihypertensive treatment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Change in antihypertensive treatment (yes or no) in relation to blood pressure values (controlled or uncontrolled blood pressure) is assessed using information collected at the GP appointment.

Secondary outcome measures

1. Change in antihypertensive treatment (yes or no) in relation to therapeutic compliance is assessed using information collected at the GP appointment
2. Change in antihypertensive treatment (yes or no) in relation to total pill burden is assessed using information collected at the GP appointment
3. Change in antihypertensive treatment (yes or no) in relation to antihypertensive pill burden is assessed using information collected at the GP appointment
4. Change in antihypertensive treatment (yes or no) in relation to type of antihypertensive treatment is assessed using information collected at the GP appointment
5. Change in antihypertensive treatment (yes or no) in relation to comorbidities/CV risk is assessed using information collected at the GP appointment
6. Change in antihypertensive treatment (yes or no) in relation to patient demographics is assessed using information collected at the GP appointment

Overall trial start date

20/01/2017

Overall trial end date

25/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Uncontrolled hypertensive patients
2. Treated with at least one antihypertensive drug
3. Consulting a general practitioner
4. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5175

Participant exclusion criteria

Secondary hypertension.

Recruitment start date

16/03/2017

Recruitment end date

08/06/2017

Locations

Countries of recruitment

Belgium, Luxembourg

Trial participating centre

Servier BeNeLux
Internationalelaan 57
Anderlecht
1070
Belgium

Sponsor information

Organisation

Servier Benelux

Sponsor details

Internationalelaan 57
Anderlecht
1070
Belgium

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Servier Benelux

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

After completion of the study a scientific report will be written and data will be send out for publication.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from bregt.vannieuwenhuyse@servier.com

Intention to publish date

25/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes