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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Other: APN intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05917600

APHP230450

2023-A00189-36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

Interventional group

Experimental group

Description:

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

Treatment:

Other: APN intervention

Control group

No Intervention group

Description:

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