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

NCT ID: NCT05917600

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2027-08-31

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

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional group

The interventional group meets an Advanced Practice Nurses (APN) between the ambulatory hospitalization (AH) and the MD consultation

Group Type: EXPERIMENTAL

APN intervention

Intervention Type: OTHER

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.

Control group

The control group of patients keeps a traditional follow-up (ambulatory hospitalization (AH) then consultation with a MD)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

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

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques BLACHER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Juliette VAY-DEMOUY, MSc, PhD

Role: STUDY_DIRECTOR

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

Locations

Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital

Paris, IDF, France

Countries

France

Central Contacts

Juliette VAY-DEMOUY, MSc, PhD student

Role: CONTACT

juliette.vaydemouy@aphp.fr

0033142348551

Marie BENHAMMANI-GODARD

Role: CONTACT

marie.godard@aphp.fr

0033158411190

Facility Contacts

Juliette VAY-DEMOUY

Role: primary

juliette.vaydemouy@aphp.fr

0033142348551

Other Identifiers

2023-A00189-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230450

Identifier Type: -

Identifier Source: org_study_id