NCT07015463Not yet recruiting
Evaluation of a Health Literacy Intervention on Patients Suffering From Hypertension in Primary Care
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 255 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- High blood pressure
- NCT number
- NCT07015463
What you commit to
- Study type: Interventional
- Planned participants: 255
- From 31 Jul 2025 to the primary completion date, 31 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient suffering from secondary hypertension.
- Patient with severe cognitive impairment or dementia.
Other
- 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
- 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.
- Patients already performing regular self-monitoring of their blood pressure.
- Healthcare professionals.
- Patient under legal protection, guardianship, or curatorship.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.