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

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.

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 exclusion criteria will be applied for this phase.

Phase 2: Evaluation of the effectiveness of the intervention

Exclusion criteria

for Investigating Physicians

• 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.

Exclusion criteria

for Patients

• 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.