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NCT07015463

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2025-07-31

Completion Date

2028-06-01

Last Updated

2025-07-31

Healthy Volunteers

Yes

Conditions

Hypertension

Interventions

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

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.