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

NCT06227884 | Completed

• 1 other identifier: APHP231667
• Study Type: observational
• Target: 483
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Advanced practice nurse; Hypertension; Therapeutic adherence; Trial

Outcome Measures

Primary Outcomes (1)

• Blood pressure (BP) control

  Blood pressure (BP) control in MD consultation * Rate of BP control (BP \< 140/90 mmHg) * Mean (SD) of both systolic and diastolic BP

  Between 2 to 12 months

Secondary Outcomes (4)

• Home blood pressure monitoring (HBPM)

  Between 2 to 12 months

• Blood pressure (BP) control

  Day hospitalization - Inclusion

• Blood pressure (BP) control

  Between 2 to 12 months

• Therapeutic adjustments

  Between 2 to 12 months

Study Arms (2)

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

Other: APN intervention

Patients without APN intervention

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

Other: No APN intervention

Interventions

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.

Patients with APN intervention

No APN intervention OTHER

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

Patients without APN intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with essential hypertension, recruited in day hospitalization unit: HDJ CITE of the Hôtel-Dieu Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

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

Location

Related Publications (1)

• 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.

  PMID: 40346888 BACKGROUND

MeSH Terms

Conditions

Hypertension; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Officials

• Jacques BLACHER, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: March 8, 2024
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (1)