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Completed

NCT Number: NCT06227884

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

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, Île-de-France Region, 75004, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APN intervention

Other

Participants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et 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.

No APN intervention

Other

Participants with a schedule of a MD consultation (within approximately 2 to 12 months)

Primary outcomes

  1. Blood pressure (BP) control

    Time frame: Between 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 outcomes

  1. Home blood pressure monitoring (HBPM)

    Time frame: 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.

  2. Blood pressure (BP) control

    Time frame: Day hospitalization - Inclusion

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

  3. Blood pressure (BP) control

    Time frame: Between 2 to 12 months

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

  4. Therapeutic adjustments

    Time frame: Between 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).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Single-center Quasi-experimental Study

Acronym: iIPArétro

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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