Hypertension
Conditions
Keywords
Advanced practice nurse, Hypertension, Therapeutic adherence, Trial
Brief summary
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
Detailed description
This study will be a prospective, open-label, randomized 1-to-1 and monocentric trial, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France. Recruitment will be conducted during the ambulatory hospitalization. After the signature of the consent form, the randomization will be conducted during the ambulatory hospitalization. All recruited patients will be randomized. According to the randomization, the odd-numbered participants will constitute the usual care group, and the even-numbered patients will constitute the intervention group. The usual care group will keep a traditional follow-up: ambulatory hospitalization then consultation with a MD within approximately 2 to 12 months. The intervention group will meet the APN between the ambulatory hospitalization and the MD consultation, within 1 to 6 months. The participants will get their study appointment(s) (MD consultation +/- APN intervention) at the end of the ambulatory hospitalization according to their allocation.
Interventions
OTHERAPN intervention
Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the MD consultation APN intervention is divided into five main steps: * clinical and paraclinical examinations, * appraisal of patient's knowledge, * health education on hypertension and treatments, * setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary * decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age, * Essential Hypertension * Hypertension management in Hôtel-Dieu Hospital * Ability to provide a written informed consent.
Exclusion criteria
* Have already benefited from an APN follow-up before the day of inclusion * Being under guardianship or curatorship * Pregnant patient * Beneficiary of the AME (state medical aid)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure control | Medical consultation, from 2 months to 12 months after inclusion | Blood pressure \< 140/90 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients who brought HBPM to consultation | Medical consultation, from 2 months to 12 months after inclusion | Ability to realize a home blood pressure measurement Blood pressure control in home blood pressure measurement (HBPM) |
| Number of measurements | Medical consultation, from 2 months to 12 months after inclusion | Ability of HBPM Quality of the HBPM : Number of measurements carried out over 3 days (18 measurements over 3 days according to protocol) then divided into 4 categories: performance (18 measurements), average performance (17 to 15 measurements), average performance (14 to 12 measurements or less), poor performance (11 measures or less). |
| Rate of Blood pressure control | Medical consultation, from 2 months to 12 months after inclusion | Difference between inclusion and the Medical consultation, from 2 months to 12 months after inclusion |
| Rate of therapeutic adjustments | Medical consultation, from 2 months to 12 months after inclusion | Rate of therapeutic adjustments due to side effects |
Countries
France
Contacts
Primary ContactJuliette VAY-DEMOUY, MSc, PhD student
Backup ContactMarie BENHAMMANI-GODARD
Outcome results
None listed