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

Not Applicable
Not yet recruiting
Conditions
Hypertension
Interventions
Other: APN intervention
Registration Number
NCT05917600
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
330
Inclusion Criteria
  • At least 18 years of age,
  • Essential Hypertension
  • Hypertension management in Hôtel-Dieu Hospital
  • Ability to provide a written informed consent.
Read More
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)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Interventional groupAPN interventionThe interventional group meets an Advanced Practice Nurses (APN) between the ambulatory hospitalization (AH) and the MD consultation
Primary Outcome Measures
NameTimeMethod
Blood pressure controlMedical consultation, from 2 months to 12 months after inclusion

Blood pressure \< 140/90 mmHg

Secondary Outcome Measures
NameTimeMethod
Rate of patients who brought HBPM to consultationMedical consultation, from 2 months to 12 months after inclusion

Ability to realize a home blood pressure measurement Blood pressure control in home blood pressure measurement (HBPM)

Number of measurementsMedical consultation, from 2 months to 12 months after inclusion

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).

Rate of Blood pressure controlMedical consultation, from 2 months to 12 months after inclusion

Difference between inclusion and the Medical consultation, from 2 months to 12 months after inclusion

Rate of therapeutic adjustmentsMedical consultation, from 2 months to 12 months after inclusion

Rate of therapeutic adjustments : other reason

Trial Locations

Locations (1)

Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital

🇫🇷

Paris, IDF, France

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