Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Other: APN intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>The interventional group meets an Advanced Practice Nurses (APN) between the ambulatory hospitalization (AH) and the MD consultation | Other: APN intervention<br>* 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.<br>|
| No Intervention: Control group<br>The control group of patients keeps a traditional follow-up (ambulatory hospitalization (AH) then consultation with a MD) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | Blood pressure < 140/90 mmHg | Medical consultation, from 2 months to 12 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who brought HBPM to consultation | Ability to realize a home blood pressure measurement Blood pressure control in home blood pressure measurement (HBPM) | Medical consultation, from 2 months to 12 months after inclusion | 
| Number of measurements | 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). | Medical consultation, from 2 months to 12 months after inclusion | 
| Rate of Blood pressure control | Difference between inclusion and the Medical consultation, from 2 months to 12 months after inclusion | Medical consultation, from 2 months to 12 months after inclusion | 
| Rate of therapeutic adjustments | Rate of therapeutic adjustments due to side effects | Medical consultation, from 2 months to 12 months after inclusion | 
| Rate of therapeutic adjustments | Rate of therapeutic adjustments due to uncontrolled hypertension | Medical consultation, from 2 months to 12 months after inclusion | 
| Rate of therapeutic adjustments | Rate of therapeutic adjustments : other reason | Medical consultation, from 2 months to 12 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced practice nurse, Hypertension, Therapeutic adherence, Trial