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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| GP of the control group | No Intervention | GP following usual guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component intervention in health literacy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | three months after the implementation of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | six months after the intervention |
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Inclusion criteria:
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
Inclusion Criteria for Investigating Physicians
General practitioners practicing:
Inclusion Criteria for Patients
Inclusion for qualitative interviews Only individuals from the intervention group will be asked to participate in these interviews.
Exclusion criteria:
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
Exclusion Criteria for Investigating Physicians
Exclusion Criteria for Patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence FRANCIS-OLIVIERO, MD | Contact | +33637932188 | francis-oliviero@irdes.fr | |
| Pierre POULIZAC | Contact | pierre.poulizac@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florence FRANCIS-OLIVIERO, MD | IRDES | Principal Investigator |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D057220 | Health Literacy |
| ID | Term |
|---|---|
| D054626 | Consumer Health Information |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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mixed-method cluster randomized trial
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| 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. | 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. | Six months after the intervention |
| Health Literacy Level | Patients' health literacy level regarding hypertension measured by the score obtained on the HLS-EU16 | 6 months after the intervention |
| Adherence to treatment scale using Girerd questionnaire | Adherence will be assessed by an investigator over the phone | 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. | 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 | 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. | 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 | 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. | 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) | Before the beginning of the randomized trial |
| D005159 | Health Care Facilities Workforce and Services |