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

NCT ID: NCT06227884

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 483 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2024-04-22

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.

Conditions

Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with APN intervention

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

Intervention Type: 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.

Patients without APN intervention

Participants with a MD consultation only, within approximately 2 to 12 months

No APN intervention

Intervention Type: OTHER

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

Interventions

APN intervention

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.

Intervention Type: OTHER

No APN intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques BLACHER, MD, PhD

Role: STUDY_CHAIR

Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris, Paris University, 75004 Paris

Locations

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

Paris, Île-de-France Region, France

Countries

France

References

Vay-Demouy J, Lelong H, Blacher J. Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: A Pilot Open-Label Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 May;27(5):e70068. doi: 10.1111/jch.70068.

Reference Type: BACKGROUND

PMID: 40346888 (View on PubMed)

Other Identifiers

APHP231667

Identifier Type: -

Identifier Source: org_study_id