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NCT Number: NCT05917600

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

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital

Paris, IDF, 75004, France

Location contact

Juliette VAY-DEMOUY

CONTACT

[email protected]

0033142348551

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

APN intervention

Other

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.

Primary outcomes

  1. Blood pressure control

    Time frame: Medical consultation, from 2 months to 12 months after inclusion

    Blood pressure < 140/90 mmHg

Secondary outcomes

  1. Rate of patients who brought HBPM to consultation

    Time frame: Medical 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)

  2. Number of measurements

    Time frame: Medical 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).

  3. Rate of Blood pressure control

    Time frame: Medical consultation, from 2 months to 12 months after inclusion

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

  4. Rate of therapeutic adjustments

    Time frame: Medical consultation, from 2 months to 12 months after inclusion

    Rate of therapeutic adjustments due to side effects

  5. Rate of therapeutic adjustments

    Time frame: Medical consultation, from 2 months to 12 months after inclusion

    Rate of therapeutic adjustments due to uncontrolled hypertension

  6. Rate of therapeutic adjustments

    Time frame: Medical consultation, from 2 months to 12 months after inclusion

    Rate of therapeutic adjustments : other reason

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette VAY-DEMOUY, MSc, PhD student

CONTACT

[email protected]

0033142348551

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

0033158411190

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: iIPA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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