Clinical trial NCT06227884: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Study
Official title: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Single-center Quasi-experimental Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertension
Keywords: Advanced practice nurse
Hypertension
Therapeutic adherence
Trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with essential hypertension, recruited in day hospitalization unit: HDJ CITE of the Hôtel-Dieu Hospital.

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: 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.

This study will be a retrospective quasi-experimental study, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France. The timeframe of the study should is from September 2020 to July 2023.

Eligibility criteria: Inclusion Criteria:

* adult patient
* being diagnosed with essential hypertension,
* being followed by a MD of the structure for hypertension management,
* having received a proposition to meet an APN for hypertension management between the day hospitalization and the next MD consultation,
* having received a loaned tensiometer with instructions during the day hospitalization and explanations for HBPM protocol.

Exclusion Criteria:

* being diagnosed with secondary hypertension,
* having APN follow-up before the day hospitalization,
* being lost to follow-up in the twelve months after the MD consultation
* not having the BP measurement by OBPM for the day hospitalization (baseline) and/or the endline (endline),
* pregnancy
* under guardianship or tutorship
* State Medical Help

Primary outcomes:
measure: Blood pressure (BP) control
timeFrame: Between 2 to 12 months
Secondary outcomes:
measure: Home blood pressure monitoring (HBPM)
timeFrame: Between 2 to 12 months
measure: Blood pressure (BP) control
timeFrame: Day hospitalization - Inclusion
measure: Blood pressure (BP) control
timeFrame: Between 2 to 12 months
measure: Therapeutic adjustments
timeFrame: Between 2 to 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris
state: Ile De France
Study officials:
affiliation: Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris, Paris University, 75004 Paris
name: Jacques BLACHER, MD, PhD
role: STUDY_CHAIR
References: