HypertensionTUN-BP-BLUENCT05516173
Role of Depression in Blood Pressure Control. Study
An observational study of Hypertension and Depression, run by General Administration of Military Health, Tunisia at 4 sites in Tunisia.
Trial summary
Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension, Depression
- What is being tested?
- Blood Pressure Monitoring, Ambulatory
- How many people
- 302 participants
- Where
- 4 sitesTunisia
- Study dates
- 15 Aug 2022to 15 Jan 2023
- 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 100 years
- All sexes
- Adult, Older adult
Study population: outpatients consulting in the cardiology department in the different participating centers .
Who may be able to join
- Patients consulting for high blood pressure
- Patients older than 18 years.
- Patients able to give informed consent.
- Non inclusion Criteria :
- Patients followed for depression under treatment.
- Hospitalized patients
Who cannot join
- a white coat hypertension
Trial locations and contacts
4 sites in 1 country.
Tunisia4 sites, 4 recruiting
- Recruiting
Regional hospital of Ben Arous
Ben Arous
Jamila Habli, MD
Ahmed ben Amara, fellow
- Not yet recruiting
Interior Security Forces Hospital
La Marsa, Tunis Governorate
Saousen Antit, Pr
Yasmine Hajri
- Recruiting
Tahar Sfar regional hospital of Mahdia
Mahdia
Hassen Ibn Hadj Amor, Pr
youssef ben youssef
- Recruiting
Military Hospital of Tunis
Tunis, 1009
Aymen NOAMEN, MD, +21620215773, no.aymen@gmail.com
Yosra Radaoui, fellow, +21695651675, yosra014590@gmail.com
About this study
Official title: Role of Depression in Blood Pressure Control. A Cross-sectional Multicentric Study
Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients.
Read the detailed description
Research Problem: Hypertension is a multifactorial disease that affects approximately one quarter of the adult population. It is a major risk factor for stroke and cardiovascular disease.
Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular-related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. the investigators intend to include three hundred and two patients. After obtaining their consent, a 24 hour ambulatory blood pressure monitor will be used to evaluate blood pressure control.
Depression was assessed by the 9-item-Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records.
- Conditions
- Hypertension, Depression
- Being tested
- Blood Pressure Monitoring, Ambulatory
- Keywords
- Patient Health Questionnaire, Blood Pressure Monitoring, Ambulatory, hypertension, depression
- Medical subject headings
- Hypertension, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure Monitoring, AmbulatoryDiagnostic test
To monitor the blood pressure during 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory patients | Patient with a high blood pressure during regular visit will undertake an ambulatory blood pressure monitoring. Before wearing the device , they will be asked to answer to the questionnaire and the investigators will gather their demographic,clinical characteristics and dietary habits data.
Ethical considerations will be undertaken and respected. Receives: Diagnostic Test: Blood Pressure Monitoring, Ambulatory |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of depression in uncontrolled hypertensive patients.
The prevalence of depression evaluated by PHQ9 in Tunisian dialect in hypertensive patients with abnormal ambulatory 24 hours blood pressure monitoring
Measured: on inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start15 Aug 2022
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Administration of Military Health, Tunisia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aymen NOAMEN, MD, Principal investigator, Military Hospital of TunisWafa Fehri, Pr, Study chair, Military Hospital of TunisLilia Zakhama, Pr, Study director, interior security forces hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516173
- Sponsor's protocol ID
- santémilitaire10
- Acronym
- TUN-BP-BLUE
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Li Y, Chen L, Chen P, Hu Y. Prevalence of Depression in Patients With Hypertension: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1317. doi: 10.1097/MD.0000000000001317.
PubMed 26252317Raddaoui Y, Ben Amara A, Noamen A, Antit S, Hajri Y, Habli J, Ibn Hadj Amor H, Ben Youssef Y, Zakhama L, Fehri W. Role of depression in blood pressure control. A cross-sectional multicentric study. Tunis Med. 2024 Jan 5;102(1):7-12. doi: 10.62438/tunismed.v102i1.4723. French.
PubMed 38545723
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Depression in Blood Pressure Control. A Cross-sectional Multicentric Study
- ClinicalTrials.gov ID
- NCT05516173
- Acronym / sponsor ID
- TUN-BP-BLUE / santémilitaire10
- Conditions
- Hypertension, Depression
- Keywords
- Patient Health Questionnaire, Blood Pressure Monitoring, Ambulatory, hypertension, depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- General Administration of Military Health, TunisiaResearch network
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 25 Aug 2022 (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.
Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients.
Detailed description
Research Problem: Hypertension is a multifactorial disease that affects approximately one quarter of the adult population. It is a major risk factor for stroke and cardiovascular disease.
Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular-related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. the investigators intend to include three hundred and two patients. After obtaining their consent, a 24 hour ambulatory blood pressure monitor will be used to evaluate blood pressure control.
Depression was assessed by the 9-item-Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory patients | – | Diagnostic Test: Blood Pressure Monitoring, AmbulatoryPatient with a high blood pressure during regular visit will undertake an ambulatory blood pressure monitoring. Before wearing the device , they will be asked to answer to the questionnaire and the investigators will gather their demographic,clinical characteristics and dietary habits data. Ethical considerations will be undertaken and respected. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- outpatients consulting in the cardiology department in the different participating centers .
Key inclusion criteria (6 listed)
- Patients consulting for high blood pressure
- Patients older than 18 years.
- Patients able to give informed consent.
- Patients followed for depression under treatment.
- Hospitalized patients
Key exclusion criteria (1 listed)
- a white coat hypertension
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 |
|---|---|---|
| Blood Pressure Monitoring, AmbulatoryTo monitor the blood pressure during 24 hours. | Diagnostic test | Ambulatory patients |
Primary outcome
prevalence of depression in uncontrolled hypertensive patients.
Time frame: on inclusion
The prevalence of depression evaluated by PHQ9 in Tunisian dialect in hypertensive patients with abnormal ambulatory 24 hours blood pressure monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Results publication: PubMed 26252317Li Z, Li Y, Chen L, Chen P, Hu Y. Prevalence of Depression in Patients With Hypertension: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1317. doi: 10.1097/MD.0000000000001317.
- Derived from this study: PubMed 38545723Raddaoui Y, Ben Amara A, Noamen A, Antit S, Hajri Y, Habli J, Ibn Hadj Amor H, Ben Youssef Y, Zakhama L, Fehri W. Role of depression in blood pressure control. A cross-sectional multicentric study. Tunis Med. 2024 Jan 5;102(1):7-12. doi: 10.62438/tunismed.v102i1.4723. French.
- 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.
Aymen NOAMEN, MD principal investigator
Military Hospital of Tunis
Wafa Fehri, Pr study chair
Military Hospital of Tunis
Lilia Zakhama, Pr study director
interior security forces hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Depression, run by General Administration of Military Health, Tunisia at 4 sites 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 6 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aymen NOAMEN, MD (+21620215773, no.aymen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of depression in uncontrolled hypertensive patients. (time frame: on inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516173, which also lists 2 linked publications.
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 26 Aug 2022.