NCT07015463

Evaluation of a Health Literacy Intervention on Patients Suffering From Hypertension in Primary Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Multi-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

Timeline

• Start date: 2025-07-31
• Primary completion: 2027-03-31
• Completion: 2028-06-01
• First posted: 2025-06-11
• Last updated: 2025-07-31