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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: APN intervention; Other: No APN intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Marie BENHAMMANI-GODARD; Phone Number: 00 33 1 58 41 11 90; Email: marie.godard@aphp.fr
• Study Contact Backup: Name: Juliette VAY-DEMOUY, MSc, PhD student; Phone Number: 00 33 1 42 34 85 51; Email: juliette.vaydemouy@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75004
      • Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris
      • Contact: Juliette VAY-DEMOUY, MSc, PhD student; Phone Number: 00 33 1 42 34 85 51; Email: juliette.vaydemouy@aphp.fr
      • Contact: Jacques BLACHER, MD, PhD; Phone Number: 00 33 1 34 85 89 66; Email: jacques.blacher@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Other: No APN intervention; Participants with a schedule of a MD consultation (within approximately 2 to 12 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home blood pressure monitoring (HBPM)	Performance and quality of home BP monitoring (HBPM). 3-category variable: HBPM perfectly performed, HBPM poorly performed, and HBPM not performed.	Between 2 to 12 months
Blood pressure (BP) control	Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled	Day hospitalization - Inclusion
Blood pressure (BP) control	Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled	Between 2 to 12 months
Therapeutic adjustments	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).	Between 2 to 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Jacques BLACHER, MD, PhD, Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris, Paris University, 75004 Paris

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Trial; Therapeutic adherence; Advanced practice nurse
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: APHP231667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No