Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control

NCT ID: NCT04448249

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-31

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.

The patients will be recruited during their visit at the day hospitalization of the Diagnosis and Therapeutic Center of Hôtel-Dieu University Hospital, for hypertension-related complications and cardiovascular risk assessment as part of their hypertension management.

Randomization/allocation will be conducted at the last moment before scheduling appointments.

The "usual care" group will keep a traditional follow-up: day hospitalization then consultation with a MD within approximately 2 to 12 months.

The "intervention" group will meet the APN between the day hospitalization and the MD consultation, within 1 to 6 months (Figure 1).

All data will be collected on site, none remotely. All information required by the protocol will be recorded on a case report form. An explanation will be provided for each missing data. The data will be collected as it is obtained and clearly transcribed into the case report form.

The primary outcome measure will be analyzed using a chi-square test. A p value <0.05 will be considered significant. Participants with missing data for this primary outcome will be considered lost to follow-up. For secondary outcome measures, a chi-square test will be used for qualitative variables compared between the two groups. A paired t-tests will be used for the differences of rate of controlled blood pressure between day hospitalization and MD consultation in each group. Non-adherent participants (APN intervention missed for the interventional group) will be considered in the statistical analysis and the rate of non-adherent participants will be mentioned in the results.Correlations between the realization and the quality of home BP monitoring in MD consultation and controlled BP will also be analyzed. No interim analyses are scheduled.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interventional group

The interventional group keeps a traditional follow up (day hospitalization then consultation with a MD within two to twelve months) but also meets an APN between the day hospitalization and the MD consultation, within one to six months

Group Type: EXPERIMENTAL

APN intervention

Intervention Type: BEHAVIORAL

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.

Control group

The control group of patients keeps a traditional follow-up: day hospitalization then consultation with a MD within two to twelve months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

APN intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• at least 18 years of age,
• treated or untreated hypertension,
• can to provide a written informed consent.

Exclusion Criteria

• age under 18 years old,
• inability to give a free informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hotel Dieu University Hospital, France

OTHER

Sponsor Role: lead

Responsible Party

Jacques Blacher

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliette VAY-DEMOUY

Role: PRINCIPAL_INVESTIGATOR

Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France

Locations

Hôpital Hôtel-Dieu

Paris, , France

Countries

France

Central Contacts

Juliette VAY-DEMOUY

Role: CONTACT

juliette.vaydemouy@aphp.fr

0142348551

Jacques BLACHER

Role: CONTACT

jacques.blacher@aphp.fr

0142348966

Facility Contacts

Juliette VAY-DEMOUY

Role: primary

juliette.vaydemouy@aphp.fr

0142348551

Jacques BLACHER

Role: backup

jacques.blacher@aphp.fr

0142348966

Other Identifiers

APN

Identifier Type: -

Identifier Source: org_study_id