HypertensionIHTALiNCT07015463
Evaluation of a Health Literacy Intervention on Patients Suffering From Hypertension in Primary Care
A study testing Multi-component intervention in health literacy in people with Hypertension, run by University Hospital, Bordeaux.
Trial summary
Hypertension affects 30% of the French population, but only 25% of hypertensive patients meet therapeutic targets, largely due to a limited adherence to lifestyle and medication guidelines (34%). Improving adherence is crucial to better blood pressure control and preventing complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Multi-component intervention in health literacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Phase 1: Co-construction of the Intervention
- o In this phase, physicians and patient representatives from patient associations or recruited through physicians will be enrolled.
- Phase 2: Evaluation of the Intervention's Effectiveness
- General practitioners practicing:
- In individual offices, in non-multidisciplinary group practices
- Or in multidisciplinary health centers or health centers
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- In Nice, Bordeaux, and Lille
- Who have expressed their non-opposition
- Willing to participate in the qualitative evaluation
- Adult French-speaking patients, able to read and write
- Suffering from essential uncontrolled and treated hypertension treated measured by home self-monitoring
- Owning a mobile phone (to be contacted for the study and to receive reminder by phone)
- Able to self-measure his/her blood pressure at home
- Who have expressed their non-opposition
- Inclusion for qualitative interviews Only individuals from the intervention group will be asked to participate in these interviews.
- All physicians who recruited patients for the trial will be invited to participate.
- A subsample of 30 patients (10 per city), selected according to the principle of maximum variation (ensuring diversity in age and gender)
Who cannot join
- Phase 1: Co-construction of the intervention
- No exclusion criteria will be applied for this phase.
- Phase 2: Evaluation of the effectiveness of the intervention
- GP who participated in the first phase of co-construction.
- GP from a health center where a collaborator has already been recruited for the study.
- GP working in collaboration with an Asalée nurse.
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- Patient suffering from secondary hypertension.
- Patient with severe cognitive impairment or dementia.
- Patients already performing regular self-monitoring of their blood pressure.
- Healthcare professionals.
- Patient under legal protection, guardianship, or curatorship.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Pierre POULIZAC contact
About this study
Hypertension affects 30% of the French population, but only 25% of hypertensive patients meet therapeutic targets, largely due to a limited adherence to lifestyle and medication guidelines (34%). Improving adherence is crucial to better blood pressure control and preventing complications. Health literacy (HL), defined by Sørensen as the ability to access, evaluate, and use health information for decision-making, has been proved associated with better adherence. Various tools, such as the "Teach-Back" method, can enhance HL but are underutilized in France due to lack of awareness and training. The objective of this study is to evaluate the effectiveness of a multi-component intervention aimed at increasing the health literacy of patients suffering from hypertension, in achieving the target blood pressure goal three months after the start of the intervention in poorly controlled hypertensive patients. The intervention will include tools (such as communication techniques) enabling physicians to enhance the health literacy of their patients.
Read the detailed description
The study comprises two phases. The first phase will involve a qualitative analysis, during which semi-structured interviews will be conducted to understand the constraints, expectations, and needs of both physicians and patients for the intervention. After this phase, an intervention following the Health Literacy Intervention Model will be constructed, through a consensus method .
The second phase of the study will be a mixed-method evaluation of the intervention's effectiveness. Initially, a cluster-randomized trial will be conducted. Thirty-six physicians will participate and randomized into either the control group or the intervention group. Each physician will recruit approximately 5 patients. Patients will undergo a pre-inclusion visit, an inclusion visit, and then three follow-up visits (at 3 and 6 months). Finally, all participating physicians and a subsample of 30 patients will take part in the qualitative study to assess the perceived effectiveness of the intervention.
- Conditions
- Hypertension
- Being tested
- Multi-component intervention in health literacy
- Keywords
- health literacy, intervention, high blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component intervention in health literacyOther
Multi-component intervention aiming at increasing the health literacy of patients suffering from hypertension, in achieving the target blood pressure goal three months after the start of the intervention in poorly controlled hypertensive patients
| Study group | Role | What they receive |
|---|---|---|
| General Practitioner (GP) exposed to the intervention | Experimental | The intervention will be developed during the first phase according to the theoretical conceptual model Health proposed by Bas Geboers. The final intervention will take the form of a standardized intervention guide containing the elements of the intervention.
Five targets respond to the theoretical model:
* Healthcare professionals, through interventions enabling them to improve their skills regarding health literacy (HL) (such as identifying HL problems in their patients, increasing their communication skills, etc.)..
* The patient and their entourage, through interventions that strengthen the support of their entourage (family, peers, etc.).
* Patients, through empowerment interventions.
* Patient-health system interaction, through interventions aimed at improving communication between patients and healthcare professionals.
* Improving blood pressure control access, through interventions focused on reducing access barriers or policies to improve the quality of care. Receives: Other: Multi-component intervention in health literacy |
| GP of the control group | No intervention | GP following usual guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a home-measured blood pressure within the therapeutic target
Proportion of patients with a home-measured blood pressure within the therapeutic target three months after the implementation of the intervention (systolic blood pressure below 140 mm Hg for patients under 80 years old or below 150 mm Hg for patients 80 years and older).
Measured: three months after the implementation of the intervention
Secondary outcomes (11)
Improvement in achieving the target blood pressure six months after the start of the intervention
Proportion of patients with blood pressure,within the therapeutic target (defined as systolic blood pressure <140 mmHg for patients under 80 years old, or <150 mmHg for patients aged 80 and over), in both groups (intervention vs. control).
Measured: six months after the intervention
Improvement in achieving the target blood pressure at three months after the start of the intervention, in GPs
Proportion of patients with blood pressure within the therapeutic target of the intervention (defined as systolic blood pressure <140 mmHg for patients under 80 years old, or <150 mmHg for patients aged 80 and over), in both groups (intervention vs. control), measured in general practitioners' offices on the day of the follow-up visit.
Measured: Three months after the intervention
Improvement in achieving the target blood pressure at six months after the start of the intervention, in GPs
Proportion of patients with blood pressure within the therapeutic target of the intervention (defined as systolic blood pressure <140 mmHg for patients under 80 years old, or <150 mmHg for patients aged 80 and over), in both groups (intervention vs. control), measured in general practitioners' offices on the day of the follow-up visit.
Measured: Six months after the intervention
Health Literacy Level
Patients' health literacy level regarding hypertension measured by the score obtained on the HLS-EU16
Measured: 6 months after the intervention
Adherence to treatment scale using Girerd questionnaire
Adherence will be assessed by an investigator over the phone
Measured: Baseline, three and six months
Effect of the Intervention by Social Categories
The proportion of patients with blood pressure within the therapeutic target will be assessed in relation to an individual index of social disadvantage (EPICES score and income level measured at baseline). The proportion of patients achieving the target blood pressure will be described by EPICES score quintiles and income level categories at each of the three time points.
Measured: Baseline, three and six months
Effective adoption of tools in the intervention group
Frequency of use of the recommended tools for each patient, and eventually extended use for other conditions
Measured: At the end of the follow-up, for each patient
Perceived effectiveness by patients
Patients' appropriation of the intervention and its impact on health-promoting behaviors, their experience and perceptions in managing the disease, and the evolution of their representations regarding their care.
Measured: During the six months after the end of the trial
Perceived effectiveness from the perspective of healthcare professionals
Actual implementation of the intervention by professionals in the intervention group. And professionals' perceived appropriation of the intervention and its impact on professional and organizational practices
Measured: During the six months after the end of the trial
Choose and adapt tools of intervention to the context of primary care
Proposition of a theory-based intervention using qualitative interviews. A standardized intervention based on the Health Literacy Intervention Model, developed in collaboration with physicians and hypertensive patients, which can be easily integrated into general practitioners' practices will be developped.
Measured: Before the beginning of the randomized trial
Investigate the factors influencing the acceptability and effectiveness of the LS intervention
Understanding of implementation contexts/ Usual behaviors of healthcare professionals/Difficulties encountered in practice and with existing health literacy tools/Needs and expectations regarding the intervention, as expressed by patient representatives and physicians (working in general practices or multidisciplinary health centers)
Measured: Before the beginning of the randomized trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
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.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- mixed-method cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence FRANCIS-OLIVIERO, MD, Principal investigator, IRDES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015463
- Sponsor's protocol ID
- CHUBX 2023/53
- Acronym
- IHTALi
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Health Literacy Intervention on Patients Suffering From Hypertension in Primary Care
- ClinicalTrials.gov ID
- NCT07015463
- Acronym / sponsor ID
- IHTALi / CHUBX 2023/53
- Conditions
- Hypertension
- Keywords
- health literacy, intervention, high blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 11 Jun 2025 (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 affects 30% of the French population, but only 25% of hypertensive patients meet therapeutic targets, largely due to a limited adherence to lifestyle and medication guidelines (34%). Improving adherence is crucial to better blood pressure control and preventing complications. Health literacy (HL), defined by Sørensen as the ability to access, evaluate, and use health information for decision-making, has been proved associated with better adherence. Various tools, such as the "Teach-Back" method, can enhance HL but are underutilized in France due to lack of awareness and training. The objective of this study is to evaluate the effectiveness of a multi-component intervention aimed at increasing the health literacy of patients suffering from hypertension, in achieving the target blood pressure goal three months after the start of the intervention in poorly controlled hypertensive patients. The intervention will include tools (such as communication techniques) enabling physicians to enhance the health literacy of their patients.
Detailed description
The study comprises two phases. The first phase will involve a qualitative analysis, during which semi-structured interviews will be conducted to understand the constraints, expectations, and needs of both physicians and patients for the intervention. After this phase, an intervention following the Health Literacy Intervention Model will be constructed, through a consensus method .
The second phase of the study will be a mixed-method evaluation of the intervention's effectiveness. Initially, a cluster-randomized trial will be conducted. Thirty-six physicians will participate and randomized into either the control group or the intervention group. Each physician will recruit approximately 5 patients. Patients will undergo a pre-inclusion visit, an inclusion visit, and then three follow-up visits (at 3 and 6 months). Finally, all participating physicians and a subsample of 30 patients will take part in the qualitative study to assess the perceived effectiveness of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- mixed-method cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| General Practitioner (GP) exposed to the intervention | Experimental | Other: Multi-component intervention in health literacyThe intervention will be developed during the first phase according to the theoretical conceptual model Health proposed by Bas Geboers. The final intervention will take the form of a standardized intervention guide containing the elements of the intervention. Five targets respond to the theoretical model: * Healthcare professionals, through interventions enabling them to improve their skills regarding health literacy (HL) (such as identifying HL problems in their patients, increasing their communication skills, etc.).. * The patient and their entourage, through interventions that strengthen the support of their entourage (family, peers, etc.). * Patients, through empowerment interventions. * Patient-health system interaction, through interventions aimed at improving communication between patients and healthcare professionals. * Improving blood pressure control access, through interventions focused on reducing access barriers or policies to improve the quality of care. |
| GP of the control group | No intervention | –GP following usual guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Phase 1: Co-construction of the Intervention
- o In this phase, physicians and patient representatives from patient associations or recruited through physicians will be enrolled.
- Phase 2: Evaluation of the Intervention's Effectiveness
- In individual offices, in non-multidisciplinary group practices
- Or in multidisciplinary health centers or health centers
Key exclusion criteria (11 listed)
- Phase 1: Co-construction of the intervention
- No exclusion criteria will be applied for this phase.
- Phase 2: Evaluation of the effectiveness of the intervention
- GP who participated in the first phase of co-construction.
- GP from a health center where a collaborator has already been recruited for the study.
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 |
|---|---|---|
| Multi-component intervention in health literacyMulti-component intervention aiming at increasing the health literacy of patients suffering from hypertension, in achieving the target blood pressure goal three months after the start of the intervention in poorly controlled hypertensive patients | Other | General Practitioner (GP) exposed to the intervention |
Primary outcome
Proportion of patients with a home-measured blood pressure within the therapeutic target
Time frame: three months after the implementation of the intervention
Proportion of patients with a home-measured blood pressure within the therapeutic target three months after the implementation of the intervention (systolic blood pressure below 140 mm Hg for patients under 80 years old or below 150 mm Hg for patients 80 years and older).
11 secondary outcomes
Improvement in achieving the target blood pressure six months after the start of the intervention
Time frame: six months after the intervention
Improvement in achieving the target blood pressure at three months after the start of the intervention, in GPs
Time frame: Three months after the intervention
Improvement in achieving the target blood pressure at six months after the start of the intervention, in GPs
Time frame: Six months after the intervention
Health Literacy Level
Time frame: 6 months after the intervention
Adherence to treatment scale using Girerd questionnaire
Time frame: Baseline, three and six months
Effect of the Intervention by Social Categories
Time frame: Baseline, three and six months
Effective adoption of tools in the intervention group
Time frame: At the end of the follow-up, for each patient
Perceived effectiveness by patients
Time frame: During the six months after the end of the trial
Perceived effectiveness from the perspective of healthcare professionals
Time frame: During the six months after the end of the trial
Choose and adapt tools of intervention to the context of primary care
Time frame: Before the beginning of the randomized trial
Investigate the factors influencing the acceptability and effectiveness of the LS intervention
Time frame: Before the beginning of the randomized trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- 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.
Pierre POULIZAC contact
Florence FRANCIS-OLIVIERO, MD principal investigator
IRDES
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component intervention in health literacy in people with Hypertension, run by University Hospital, Bordeaux.
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 17 inclusion and 11 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence FRANCIS-OLIVIERO, MD (+33637932188, francis-oliviero@irdes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a home-measured blood pressure within the therapeutic target (time frame: three months after the implementation of the intervention). 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 31 Jul 2025.