Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control (iIPA)

Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial

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

Detailed Description

This study will be a prospective, open-label, randomized 1-to-1 and monocentric trial, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France.

Recruitment will be conducted during the ambulatory hospitalization. After the signature of the consent form, the randomization will be conducted during the ambulatory hospitalization. All recruited patients will be randomized.

According to the randomization, the odd-numbered participants will constitute the "usual care" group, and the even-numbered patients will constitute the "intervention" group.

The "usual care" group will keep a traditional follow-up: ambulatory hospitalization then consultation with a MD within approximately 2 to 12 months.

The "intervention" group will meet the APN between the ambulatory hospitalization and the MD consultation, within 1 to 6 months.

The participants will get their study appointment(s) (MD consultation +/- APN intervention) at the end of the ambulatory hospitalization according to their allocation.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Benhammani-Godard; Phone Number: 0033158411190; Email: marie.godard@aphp.fr
• Study Contact Backup: Name: Juliette VAY-DEMOUY, MSc, PhD student; Phone Number: 0033142348551; Email: juliette.vaydemouy@aphp.fr

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75004
      • Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital
      • Contact: Juliette VAY-DEMOUY; Phone Number: 0033142348551; Email: juliette.vaydemouy@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years of age,
• Essential Hypertension
• Hypertension management in Hôtel-Dieu Hospital
• Ability to provide a written informed consent.

Exclusion Criteria:

• Have already benefited from an APN follow-up before the day of inclusion
• Being under guardianship or curatorship
• Pregnant patient
• Beneficiary of the AME (state medical aid)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; The interventional group meets an Advanced Practice Nurses (APN) between the ambulatory hospitalization (AH) and the MD consultation	Other: APN intervention; Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the 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 Intervention: Control group; The control group of patients keeps a traditional follow-up (ambulatory hospitalization (AH) then consultation with a MD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control	Blood pressure < 140/90 mmHg	Medical consultation, from 2 months to 12 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients who brought HBPM to consultation	Ability to realize a home blood pressure measurement Blood pressure control in home blood pressure measurement (HBPM)	Medical consultation, from 2 months to 12 months after inclusion
Number of measurements	Ability of HBPM Quality of the HBPM : Number of measurements carried out over 3 days (18 measurements over 3 days according to protocol) then divided into 4 categories: performance (18 measurements), average performance (17 to 15 measurements), average performance (14 to 12 measurements or less), poor performance (11 measures or less).	Medical consultation, from 2 months to 12 months after inclusion
Rate of Blood pressure control	Difference between inclusion and the Medical consultation, from 2 months to 12 months after inclusion	Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments	Rate of therapeutic adjustments due to side effects	Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments	Rate of therapeutic adjustments due to uncontrolled hypertension	Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments	Rate of therapeutic adjustments : other reason	Medical consultation, from 2 months to 12 months after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jacques BLACHER, MD, PhD, Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris; Study Director: Juliette VAY-DEMOUY, MSc, PhD, Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: May 1, 2023

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: APHP230450; 2023-A00189-36 (Other Identifier: ANSM)

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