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

NCT ID: NCT07015463

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2028-06-01

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

General Practitioner (GP) exposed to the intervention

The intervention will be developed during the first phase according to the theoretical conceptual model Health proposed by Bas Geboers. The final intervention will take the form of a standardized intervention guide containing the elements of the intervention.

Five targets respond to the theoretical model:

• Healthcare professionals, through interventions enabling them to improve their skills regarding health literacy (HL) (such as identifying HL problems in their patients, increasing their communication skills, etc.)..
• The patient and their entourage, through interventions that strengthen the support of their entourage (family, peers, etc.).
• Patients, through empowerment interventions.
• Patient-health system interaction, through interventions aimed at improving communication between patients and healthcare professionals.
• Improving blood pressure control access, through interventions focused on reducing access barriers or policies to improve the quality of care.

Group Type: EXPERIMENTAL

Multi-component intervention in health literacy

Intervention Type: OTHER

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

GP of the control group

GP following usual guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

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

• 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

Phase 2: Evaluation of the effectiveness of the intervention

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence FRANCIS-OLIVIERO, MD

Role: PRINCIPAL_INVESTIGATOR

IRDES

Central Contacts

Florence FRANCIS-OLIVIERO, MD

Role: CONTACT

francis-oliviero@irdes.fr

+33637932188

Pierre POULIZAC

Role: CONTACT

pierre.poulizac@chu-bordeaux.fr

Other Identifiers

CHUBX 2023/53

Identifier Type: -

Identifier Source: org_study_id