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

Hypertension Clinical Trial

— iIPArétro  

Official title:

Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Single-center Quasi-experimental Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06227884
• Other study ID #: APHP231667
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Juliette VAY-DEMOUY, MSc, PhD student
• Phone: 00 33 1 42 34 85 51
• Email: juliette.vaydemouy[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

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:

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. This study will be a retrospective quasi-experimental study, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France. The timeframe of the study should is from September 2020 to July 2023.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient
• being diagnosed with essential hypertension,
• being followed by a MD of the structure for hypertension management,
• having received a proposition to meet an APN for hypertension management between the day hospitalization and the next MD consultation,
• having received a loaned tensiometer with instructions during the day hospitalization and explanations for HBPM protocol.

Exclusion Criteria:

• being diagnosed with secondary hypertension,
• having APN follow-up before the day hospitalization,
• being lost to follow-up in the twelve months after the MD consultation
• not having the BP measurement by OBPM for the day hospitalization (baseline) and/or the endline (endline),
• pregnancy
• under guardianship or tutorship
• State Medical Help

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• APN intervention
Participants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et 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.
• No APN intervention
Participants with a schedule of a MD consultation (within approximately 2 to 12 months)

Locations

Country	Name	City	State
France	Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris	Paris	Ile De France

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 (BP) control	Blood pressure (BP) control in MD consultation; Rate of BP control (BP < 140/90 mmHg); Mean (SD) of both systolic and diastolic BP	Between 2 to 12 months
Secondary	Home blood pressure monitoring (HBPM)	Performance and quality of home BP monitoring (HBPM). 3-category variable: HBPM perfectly performed, HBPM poorly performed, and HBPM not performed.	Between 2 to 12 months
Secondary	Blood pressure (BP) control	Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled	Day hospitalization - Inclusion
Secondary	Blood pressure (BP) control	Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled	Between 2 to 12 months
Secondary	Therapeutic adjustments	Group with APN : Therapeutic adjustments and their indication(s) by the APN. Dichotomous variables: therapeutic adjustments (yes/no) and their indication(s): inefficacy (yes/no) and intolerance (yes/no).	Between 2 to 12 months