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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
See additional file (ISRCTN16199080_BasicResults_11Dec18.pdf)
Publication list
Publication citations
Additional files
- ISRCTN16199080_BasicResults_11Dec18.pdf Uploaded 11/12/2018