Clinical trial NCT04448249: Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control
Official title: Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Advanced Pratice Nurse
Hypertension
Lead sponsor: Hotel Dieu University Hospital, France
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of home blood pressure monitoring brought to MD consultation
timeFrame: 12 months
measure: Quality of the home blood pressure monitoring brought to MD consultation
timeFrame: 12 months
measure: Rate of therapeutic adjustments during the APN intervention
timeFrame: 6 months
measure: Indication(s) of therapeutic adjustments during the APN intervention
timeFrame: 6 months
measure: Difference in rates of controlled blood pressure (office blood pressure < 140/90 mmHg) between day hospitalization and MD consultation in each group.
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hôtel-Dieu
Study officials:
affiliation: Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France
name: Juliette VAY-DEMOUY
role: PRINCIPAL_INVESTIGATOR
References: