Clinical trial NCT05917600: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control
Official title: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Advanced practice nurse
Hypertension
Therapeutic adherence
Trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Blood pressure control
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
Secondary outcomes:
measure: Rate of patients who brought HBPM to consultation
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
measure: Number of measurements
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
measure: Rate of Blood pressure control
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
measure: Rate of therapeutic adjustments
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
measure: Rate of therapeutic adjustments
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
measure: Rate of therapeutic adjustments
timeFrame: Medical consultation, from 2 months to 12 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital
state: IDF
Study officials:
affiliation: Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
name: Jacques BLACHER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
name: Juliette VAY-DEMOUY, MSc, PhD
role: STUDY_DIRECTOR
References: