Hypertension,EssentialNCT06517134
Prescribing Patterns of Antihypertensive Drugs in Uncomplicated Hypertension
An observational study of Hypertension,Essential and Cardiovascular Diseases, run by University Hospital, Caen at 1 site in France.
Trial summary
Hypertension incurs substantial cardiovascular morbidity and mortality, particularly in primary prevention settings. General practitioners (GPs) play a pivotal role in the management of hypertension in primary care, yet variations exist among GPs. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension,Essential, Cardiovascular Diseases
- What is being tested?
- Antihypertensive Agents
- How many people
- 3,325,032 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 5 Jun 2024
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participant pool for this study comprised GP characteristics and prescription practices within the Normandy region in northwestern France during the course of 2019. With a resident population of 3,325,032 as of January 1, 2019, and a total of 2,165 registered GPs, the study was well-situated to offer a representative analysis. In order to focus on conventional full-time primary GP care, practitioners whose primary professional focus included specialties such as osteopathy, acupuncture, homeopathy, or nutrition were excluded. Furthermore, GPs with fewer than 300 annual consultations/visits (less than one per day), fewer than 2,000 annual drug prescriptions, no patients with any of the 30 chronic diseases that qualify for no-charge treatment under French law, or solely very low-income patients (eligible for no-charge GP visits as defined by French legislation) were also excluded.
Who may be able to join
- All patients who had at least one visit to their GP in 2019 were included, but minors were omitted.
Who cannot join
- minors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between GP Characteristics and Prescription Patterns for Antihypertensive Drugs: A Cross-sectional Study in Normandy, France
Hypertension incurs substantial cardiovascular morbidity and mortality, particularly in primary prevention settings. General practitioners (GPs) play a pivotal role in the management of hypertension in primary care, yet variations exist among GPs. The determinants shaping GPs' antihypertensive medication (AD) prescription patterns in the setting of hypertension remain ambiguous. This investigation sought to elucidate how GPs' characteristics and professional activities influence AD prescriptions. A cross-sectional study utilizing a sample of 2,165 GPs was conducted in Normandy, France, in 2019. The ratio of AD prescriptions to overall prescription volume was computed for each practitioner. GPs were classified as 'low' or 'high' AD prescribers based on the median of this ratio. The ratio was examined in relation to GPs' demographic and professional variables such as age, gender, practice setting, years of experience, consultation frequency, the demographics and socioeconomic status of their patient panels, and prevalence of chronic conditions in patients. These associations were explored using both univariate and multivariate analyses.
- Conditions
- Hypertension,Essential, Cardiovascular Diseases
- Being tested
- Antihypertensive Agents
- Keywords
- hypertension, prescriptions, primary care
- Medical subject headings
- Essential Hypertension, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive AgentsDrug
use of antihypertensive drugs
| Study group | Role | What they receive |
|---|---|---|
| hypertensive subjects | Not described Receives: Drug: Antihypertensive Agents | |
| non-hypertensive subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
GP demographics
age and gender of GPs, the urban or rural classification of the practice location (based on the GP's clinic postal code and DATASANTE tables from the French National Institute for Statistics and Economic Studies, INSEE), and the number of years in practice.
Measured: 1 year
medical practice activities
frequency of home visits and consultations, the total number of registered patients, the average number of visits or consultations per patient, the average patient age, the number of very low-income patients, and the prevalence of registered chronic diseases (notably diabetes mellitus and cardiovascular 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 posted24 Jul 2024
- Study start1 Jan 2019
- Primary completion12 Aug 2022
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,325,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier HUMBERT, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517134
- Sponsor's protocol ID
- 24-01
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between GP Characteristics and Prescription Patterns for Antihypertensive Drugs: A Cross-sectional Study in Normandy, France
- ClinicalTrials.gov ID
- NCT06517134
- Acronym / sponsor ID
- 24-01
- Conditions
- Hypertension,Essential, Cardiovascular Diseases
- Keywords
- hypertension, prescriptions, primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,325,032 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- 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.
Hypertension incurs substantial cardiovascular morbidity and mortality, particularly in primary prevention settings. General practitioners (GPs) play a pivotal role in the management of hypertension in primary care, yet variations exist among GPs. The determinants shaping GPs' antihypertensive medication (AD) prescription patterns in the setting of hypertension remain ambiguous. This investigation sought to elucidate how GPs' characteristics and professional activities influence AD prescriptions. A cross-sectional study utilizing a sample of 2,165 GPs was conducted in Normandy, France, in 2019. The ratio of AD prescriptions to overall prescription volume was computed for each practitioner. GPs were classified as 'low' or 'high' AD prescribers based on the median of this ratio. The ratio was examined in relation to GPs' demographic and professional variables such as age, gender, practice setting, years of experience, consultation frequency, the demographics and socioeconomic status of their patient panels, and prevalence of chronic conditions in patients. These associations were explored using both univariate and multivariate analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive subjects | – | Drug: Antihypertensive Agents |
| non-hypertensive subjects | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participant pool for this study comprised GP characteristics and prescription practices within the Normandy region in northwestern France during the course of 2019. With a resident population of 3,325,032 as of January 1, 2019, and a total of 2,165 registered GPs, the study was well-situated to offer a representative analysis. In order to focus on conventional full-time primary GP care, practitioners whose primary professional focus included specialties such as osteopathy, acupuncture, homeopathy, or nutrition were excluded. Furthermore, GPs with fewer than 300 annual consultations/visits (less than one per day), fewer than 2,000 annual drug prescriptions, no patients with any of the 30 chronic diseases that qualify for no-charge treatment under French law, or solely very low-income patients (eligible for no-charge GP visits as defined by French legislation) were also excluded.
Key inclusion criteria (1 listed)
- All patients who had at least one visit to their GP in 2019 were included, but minors were omitted.
Key exclusion criteria (1 listed)
- minors
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 |
|---|---|---|
| Antihypertensive Agentsuse of antihypertensive drugs | Drug | hypertensive subjects |
Primary outcome
GP demographics
Time frame: 1 year
age and gender of GPs, the urban or rural classification of the practice location (based on the GP's clinic postal code and DATASANTE tables from the French National Institute for Statistics and Economic Studies, INSEE), and the number of years in practice.
medical practice activities
Time frame: 1 year
frequency of home visits and consultations, the total number of registered patients, the average number of visits or consultations per patient, the average patient age, the number of very low-income patients, and the prevalence of registered chronic diseases (notably diabetes mellitus and cardiovascular diseases).
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 25 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential and Cardiovascular Diseases, run by University Hospital, Caen at 1 site in France.
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 1 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 25 Jul 2024. 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 France. 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?
GP demographics (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.