Clinical trial NCT07015463: Evaluation of a Health Literacy Intervention on Patients Suffering From Hypertension in Primary Care
Official title: Evaluation of a Health Literacy Intervention on Patients Suffering From Hypertension in Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: health literacy
intervention
high blood pressure
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mixed-method cluster randomized trial
Primary purpose: OTHER

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.

Eligibility criteria: 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)
* 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.

Primary outcomes:
measure: Proportion of patients with a home-measured blood pressure within the therapeutic target
timeFrame: three months after the implementation of the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IRDES
name: Florence FRANCIS-OLIVIERO, MD
role: PRINCIPAL_INVESTIGATOR
References: