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

Not yet recruiting
Conditions
Hypertension
Interventions
Other: No APN intervention
Other: APN intervention
Registration Number
NCT06227884
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
400
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.
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients without APN interventionNo APN interventionParticipants with a MD consultation only, within approximately 2 to 12 months
Patients with APN interventionAPN interventionParticipants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et MD consultation
Primary Outcome Measures
NameTimeMethod
Blood pressure (BP) controlBetween 2 to 12 months

Blood pressure (BP) control in MD consultation

* Rate of BP control (BP \< 140/90 mmHg)

* Mean (SD) of both systolic and diastolic BP

Secondary Outcome Measures
NameTimeMethod
Therapeutic adjustmentsBetween 2 to 12 months

Group with APN :

Therapeutic adjustments and their indication(s) by the APN. Dichotomous variables: therapeutic adjustments (yes/no) and their indication(s): inefficacy (yes/no) and intolerance (yes/no).

Blood pressure (BP) controlBetween 2 to 12 months

Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled

Home blood pressure monitoring (HBPM)Between 2 to 12 months

Performance and quality of home BP monitoring (HBPM). 3-category variable: HBPM perfectly performed, HBPM poorly performed, and HBPM not performed.

Trial Locations

Locations (1)

Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris

🇫🇷

Paris, Ile De France, France

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