HypertensionSALOON-HTNNCT04197401
Screening & Health Education in Barbershop Centers for Hypertension
An observational study of Hypertension, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
SALOON-HTN is a cross-sectional, descriptive, non-interventional, multicenter survey aiming to screen high blood pressure by measuring blood pressure in barbershops. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 1,536 participants
- Where
- 1 siteTunisia
- Study dates
- 13 Sep 2019to 25 Nov 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population to enroll is represented by all men and women who are willing to screen their blood pressure level at the barbershops of Metline Township (located at Bizerte town, in the North of Tunisia).
Who may be able to join
- Age > 18 years old
- Informed Consent to participate in the screening study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
SALOON-HTN is a cross-sectional, descriptive, non-interventional, multicenter survey aiming to screen high blood pressure by measuring blood pressure in barbershops.
Read the detailed description
The survey is a screening project for hypertension, which will enroll subjects at the barbershops. The Metline Township (located at Bizerte Town, in the north of Tunisia) will be the geographical area of population enrollment. Barbershops hairdressers will be trained by a medical staff to measure the blood pressure by an ambulatory device.
All subjects willing to participate in the survey will be asked to measure their blood pressure by after at least 5 minutes rest. Three measures will be performed by the Hairdressers, with an interval of 3 minutes between each measure. The mean of the last two measures will be considered. If the mean blood pressure level exceeds 135/85 mmHg the subject will be sent to a physician of his choice.
- Conditions
- Hypertension
- Keywords
- Barbershop, Screening, Health Education, Cardiology, DACIMA Clinical Suite
- Medical subject headings
- Hypertension, Health Education
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension frequency
Number of subjects with systolic blood pressure above 135 mmHg and/or diastolic blood pressure above 85 mmHg
Measured: at inclusion
Controlled Hypertensive patients
Number of subjects with known hypertension having systolic blood pressure below 135 mmHg and diastolic blood pressure below 85 mmHg
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start13 Sep 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
- Responsible party
- Sponsor
- Investigators
- Faouzi Addad, MD, Study chair, Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197401
- Sponsor's protocol ID
- DAC-007-SALOONHTN
- Acronym
- SALOON-HTN
- Status last verified
- Oct 2020
- First submitted
- 11 Dec 2019
- Last updated
- 6 Oct 2020
- 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening & Health Education in Barbershop Centers for Hypertension
- ClinicalTrials.gov ID
- NCT04197401
- Acronym / sponsor ID
- SALOON-HTN / DAC-007-SALOONHTN
- Conditions
- Hypertension
- Keywords
- Barbershop, Screening, Health Education, Cardiology, DACIMA Clinical Suite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,536 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 13 Dec 2019 (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.
SALOON-HTN is a cross-sectional, descriptive, non-interventional, multicenter survey aiming to screen high blood pressure by measuring blood pressure in barbershops.
Detailed description
The survey is a screening project for hypertension, which will enroll subjects at the barbershops. The Metline Township (located at Bizerte Town, in the north of Tunisia) will be the geographical area of population enrollment. Barbershops hairdressers will be trained by a medical staff to measure the blood pressure by an ambulatory device.
All subjects willing to participate in the survey will be asked to measure their blood pressure by after at least 5 minutes rest. Three measures will be performed by the Hairdressers, with an interval of 3 minutes between each measure. The mean of the last two measures will be considered. If the mean blood pressure level exceeds 135/85 mmHg the subject will be sent to a physician of his choice.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population to enroll is represented by all men and women who are willing to screen their blood pressure level at the barbershops of Metline Township (located at Bizerte town, in the North of Tunisia).
Key inclusion criteria (2 listed)
- Age > 18 years old
- Informed Consent to participate in the screening study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension frequency
Time frame: at inclusion
Number of subjects with systolic blood pressure above 135 mmHg and/or diastolic blood pressure above 85 mmHg
Controlled Hypertensive patients
Time frame: at inclusion
Number of subjects with known hypertension having systolic blood pressure below 135 mmHg and diastolic blood pressure below 85 mmHg
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 6 Oct 2020.
- Screening and health education in barbershop centers for hypertension (SALOON-HTN) : ESC Congress 2020Link provided by the sponsor.
- 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.
Faouzi Addad, MD study chair
Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire
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, run by Dacima Consulting at 1 site in Tunisia.
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 2 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 6 Oct 2020. 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 Tunisia. 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?
Hypertension frequency (time frame: at inclusion). 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 6 Oct 2020.