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

Hypertension Clinical Trial

— iIPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917600
• Other study ID #: APHP230450
• Secondary ID: 2023-A00189-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: August 2027

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Juliette VAY-DEMOUY, MSc, PhD student
• Phone: 0033142348551
• Email: juliette.vaydemouy[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: August 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• APN intervention
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.

Locations

Country	Name	City	State
France	Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure control	Blood pressure < 140/90 mmHg	Medical consultation, from 2 months to 12 months after inclusion
Secondary	Rate of patients who brought HBPM to consultation	Ability to realize a home blood pressure measurement Blood pressure control in home blood pressure measurement (HBPM)	Medical consultation, from 2 months to 12 months after inclusion
Secondary	Number of measurements	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).	Medical consultation, from 2 months to 12 months after inclusion
Secondary	Rate of Blood pressure control	Difference between inclusion and the Medical consultation, from 2 months to 12 months after inclusion	Medical consultation, from 2 months to 12 months after inclusion
Secondary	Rate of therapeutic adjustments	Rate of therapeutic adjustments due to side effects	Medical consultation, from 2 months to 12 months after inclusion
Secondary	Rate of therapeutic adjustments	Rate of therapeutic adjustments due to uncontrolled hypertension	Medical consultation, from 2 months to 12 months after inclusion
Secondary	Rate of therapeutic adjustments	Rate of therapeutic adjustments : other reason	Medical consultation, from 2 months to 12 months after inclusion