Screening & Health Education in Barbershop Centers for Hy... | NCT04197401

Studies
Screening & Health Education in Barbershop Centers for Hypertension

NCT04197401

Sponsor

Dacima Consulting

Status

Completed

Last Update Posted

Oct 6, 2020Actual

Enrollment

1,536Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Not provided

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2019Actual

Primary Completion Date

Nov 25, 2019Actual

Completion Date

Nov 25, 2019Actual

First Submitted Date

Dec 11, 2019

First Submission Date that Met QC Criteria

Dec 11, 2019

First Posted Date

Dec 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2020

Last Update Posted Date

Oct 6, 2020Actual

Name	Class
Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,536Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypertension frequency	Number of subjects with systolic blood pressure above 135 mmHg and/or diastolic blood pressure above 85 mmHg	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	at inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
Informed Consent to participate in the screening study

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Faouzi Addad, MD	Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barbershops (N = 27)		Al Matlīn	Bizerte Governorate	7000	Tunisia

References Module

Citations

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000099060	Adherence Interventions
D055118	Medication Adherence