Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control

NCT04448249 | Unknown DMC

• 1 other identifier: APN
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Advanced Pratice Nurse; Hypertension

Outcome Measures

Primary Outcomes (1)

• Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)

  According to the European and International guidelines, the protocol for office BP measurement will be: 5 minutes rest, 3 measurements at one-minute intervals in supine position followed by 3 standing measurements at one-minute intervals for orthostatic hypotension test. Unattended office blood pressure measurement will be conducted thanks to a supervisor (usually a nurse) who will explain the protocol to the patient before letting him rest in a quiet room and thanks to an automatic sphygmomanometer that can print the statement of measures at the end of the monitoring. Blood pressure level will be estimated by the average of the 2 last blood pressure measures in supine position. We will consider that blood pressure is controlled if systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg.

  12 months

Secondary Outcomes (5)

• Rate of home blood pressure monitoring brought to MD consultation

  12 months

• Quality of the home blood pressure monitoring brought to MD consultation

  12 months

• Rate of therapeutic adjustments during the APN intervention

  6 months

• Indication(s) of therapeutic adjustments during the APN intervention

  6 months

• Difference in rates of controlled blood pressure (office blood pressure < 140/90 mmHg) between day hospitalization and MD consultation in each group.

  12 months

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Behavioral: APN intervention

Control group

NO INTERVENTION

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

Interventions

APN intervention 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.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hotel Dieu University Hospital, France: lead

Study Sites (1)

Hôpital Hôtel-Dieu

Paris, France

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juliette VAY-DEMOUY

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette VAY-DEMOUY

CONTACT

0142348551; juliette.vaydemouy@aphp.fr

Jacques BLACHER

CONTACT

0142348966; jacques.blacher@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 25, 2020
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

FR (1)