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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Blood pressure control [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]

Вторичные конечные точки (6)

• Rate of patients who brought HBPM to consultation [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]
• Number of measurements [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]
• Rate of Blood pressure control [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]
• Rate of therapeutic adjustments [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]
• Rate of therapeutic adjustments [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]
• Rate of therapeutic adjustments [Срок оценки: Medical consultation, from 2 months to 12 months after inclusion]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital — Paris

Идентификаторы

NCT: NCT05917600 · APHP230450 · 2023-A00189-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗