Clinical Trials Logo

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
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A