Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 330
- Locations
- 2
- Primary Endpoint
- Blood pressure control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Blood pressure control
Time Frame: Medical consultation, from 2 months to 12 months after inclusion
Blood pressure \< 140/90 mmHg
Secondary Outcomes
- Rate of patients who brought HBPM to consultation(Medical consultation, from 2 months to 12 months after inclusion)
- Number of measurements(Medical consultation, from 2 months to 12 months after inclusion)
- Rate of Blood pressure control(Medical consultation, from 2 months to 12 months after inclusion)
- Rate of therapeutic adjustments(Medical consultation, from 2 months to 12 months after inclusion)