Hypertension
Conditions
Keywords
health literacy, intervention, high blood pressure
Brief 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. 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.
Interventions
OTHERMulti-component intervention in health literacy
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
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
mixed-method cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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: * In individual offices, in non-multidisciplinary group practices * Or in multidisciplinary health centers or health centers * In Nice, Bordeaux, and Lille * Who have expressed their non-opposition * Willing to participate in the qualitative evaluation Inclusion Criteria for Patients * 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)
Exclusion criteria
Phase 1: Co-construction of the intervention No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a home-measured blood pressure within the therapeutic target | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in achieving the target blood pressure six months after the start of the intervention | six months after 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). |
| Improvement in achieving the target blood pressure at three months after the start of the intervention, in GPs | Three months after the intervention | 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. |
| Improvement in achieving the target blood pressure at six months after the start of the intervention, in GPs | Six months after the intervention | 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. |
| Health Literacy Level | 6 months after the intervention | Patients' health literacy level regarding hypertension measured by the score obtained on the HLS-EU16 |
| Adherence to treatment scale using Girerd questionnaire | Baseline, three and six months | Adherence will be assessed by an investigator over the phone |
| Effective adoption of tools in the intervention group | At the end of the follow-up, for each patient | Frequency of use of the recommended tools for each patient, and eventually extended use for other conditions |
| Perceived effectiveness by patients | During the six months after the end of the trial | 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. |
| Perceived effectiveness from the perspective of healthcare professionals | During the six months after the end of the trial | 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 |
| Choose and adapt tools of intervention to the context of primary care | Before the beginning of the randomized trial | 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. |
| Investigate the factors influencing the acceptability and effectiveness of the LS intervention | Before the beginning of the randomized trial | 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) |
| Effect of the Intervention by Social Categories | Baseline, three and six months | 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. |
Contacts
Primary ContactFlorence FRANCIS-OLIVIERO, MD
Backup ContactPierre POULIZAC
Outcome results
None listed