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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	5 September 2022
Main ID:	ISRCTN16199080
Date of registration:	05/04/2017
Prospective Registration:	No
Primary sponsor:	Servier Benelux
Public title:	Evaluation of the motivation and key drivers of general practitioners in Belgium and Luxembourg to SIMPLIFY or intensify antihypertensive treatment in uncontrolled hypertensive patients
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
Date of first enrolment:	16/03/2017
Target sample size:	5175
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN16199080
Study type:	Observational
Study design:	Cross-sectional observational study (Treatment)
Phase:	Not Applicable

Countries of recruitment
Belgium	Luxembourg

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Bregt Van Nieuwenhuyse
Address:	Servier Benelux Internationalelaan 57 1070 Anderlecht Belgium
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Exclusion criteria: Secondary hypertension.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension
Circulatory System
Hypertension

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

VI 17/01/20/01

Source(s) of Monetary Support

Servier Benelux

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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)

Results

Results available:	Yes
Date Posted:
Date Completed:	25/09/2017
URL:

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