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

NCT07015463 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/53
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

health literacy; intervention; high blood pressure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a home-measured blood pressure within the therapeutic target

  Proportion of patients with a home-measured blood pressure within the therapeutic target three months after the implementation of the intervention (systolic blood pressure below 140 mm Hg for patients under 80 years old or below 150 mm Hg for patients 80 years and older).

  three months after the implementation of the intervention

Secondary Outcomes (11)

• Improvement in achieving the target blood pressure six months after the start of the intervention

  six months after the intervention

• Improvement in achieving the target blood pressure at three months after the start of the intervention, in GPs

  Three months after the intervention

• Improvement in achieving the target blood pressure at six months after the start of the intervention, in GPs

  Six months after the intervention

• Health Literacy Level

  6 months after the intervention

• Adherence to treatment scale using Girerd questionnaire

  Baseline, three and six months

Study Arms (2)

General Practitioner (GP) exposed to the intervention

EXPERIMENTAL

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.

Other: Multi-component intervention in health literacy

GP of the control group

NO INTERVENTION

GP following usual guidelines

Interventions

Multi-component intervention in health literacy 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

General Practitioner (GP) exposed to the intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• All physicians who recruited patients for the trial will be invited to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Hypertension

Interventions

Health Literacy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Consumer Health Information; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Florence FRANCIS-OLIVIERO, MD

  IRDES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence FRANCIS-OLIVIERO, MD

CONTACT

+33637932188; francis-oliviero@irdes.fr

Pierre POULIZAC

CONTACT

pierre.poulizac@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mixed-method cluster randomized trial

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share