NCT05917600

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
15mo left

Started Jun 2023

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jun 2023Aug 2027

Study Start

First participant enrolled

June 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 26, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

June 14, 2023

Last Update Submit

June 14, 2023

Conditions

Hypertension

Keywords

Advanced practice nurseHypertensionTherapeutic adherenceTrial

Outcome Measures

Primary Outcomes (1)

  • Blood pressure control

    Blood pressure \< 140/90 mmHg

    Medical consultation, from 2 months to 12 months after inclusion

Secondary Outcomes (6)

  • 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

  • Rate of therapeutic adjustments

    Medical consultation, from 2 months to 12 months after inclusion

  • +1 more secondary outcomes

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Other: APN intervention

Control group

NO INTERVENTION

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

Interventions

APN interventionOTHER

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.

Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Being under guardianship or curatorship
  • Pregnant patient
  • Beneficiary of the AME (state medical aid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital

Paris, IDF, 75004, France

Location

MeSH Terms

Conditions

HypertensionTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHealth BehaviorBehavior

Study Officials

  • Jacques BLACHER, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Juliette VAY-DEMOUY, MSc, PhD

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

    STUDY DIRECTOR

Central Study Contacts

Juliette VAY-DEMOUY, MSc, PhD student

CONTACT

0033142348551juliette.vaydemouy@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

0033158411190marie.godard@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 26, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 26, 2023

Record last verified: 2023-05

Locations

FR(1)