<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448249</url>
  </required_header>
  <id_info>
    <org_study_id>APN</org_study_id>
    <nct_id>NCT04448249</nct_id>
  </id_info>
  <brief_title>Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control</brief_title>
  <official_title>Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hotel Dieu University Hospital, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hotel Dieu University Hospital, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension is the most frequent chronic pathology in France and in the world. It is one of&#xD;
      the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are&#xD;
      uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive&#xD;
      treatment. Poor adherence to drug treatments is considered as one of the main causes of&#xD;
      non-control of hypertension. Since 2018, a new profession has entered the French healthcare&#xD;
      system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of&#xD;
      nursing and medical exercises. The purpose of this interventional study is to assess the&#xD;
      impact of APN on blood pressure (BP) control in the context of usual care of hypertension&#xD;
      thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis&#xD;
      formulated is that an individual APN intervention, included in a usual hypertension&#xD;
      management, improves BP control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective, open-label, randomized 1-to-1 and monocentric trial,&#xD;
      conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital,&#xD;
      Assistance Publique - Hôpitaux de Paris, France.&#xD;
&#xD;
      The patients will be recruited during their visit at the day hospitalization of the Diagnosis&#xD;
      and Therapeutic Center of Hôtel-Dieu University Hospital, for hypertension-related&#xD;
      complications and cardiovascular risk assessment as part of their hypertension management.&#xD;
&#xD;
      Randomization/allocation will be conducted at the last moment before scheduling appointments.&#xD;
&#xD;
      The &quot;usual care&quot; group will keep a traditional follow-up: day hospitalization then&#xD;
      consultation with a MD within approximately 2 to 12 months.&#xD;
&#xD;
      The &quot;intervention&quot; group will meet the APN between the day hospitalization and the MD&#xD;
      consultation, within 1 to 6 months (Figure 1).&#xD;
&#xD;
      All data will be collected on site, none remotely. All information required by the protocol&#xD;
      will be recorded on a case report form. An explanation will be provided for each missing&#xD;
      data. The data will be collected as it is obtained and clearly transcribed into the case&#xD;
      report form.&#xD;
&#xD;
      The primary outcome measure will be analyzed using a chi-square test. A p value &lt;0.05 will be&#xD;
      considered significant. Participants with missing data for this primary outcome will be&#xD;
      considered lost to follow-up. For secondary outcome measures, a chi-square test will be used&#xD;
      for qualitative variables compared between the two groups. A paired t-tests will be used for&#xD;
      the differences of rate of controlled blood pressure between day hospitalization and MD&#xD;
      consultation in each group. Non-adherent participants (APN intervention missed for the&#xD;
      interventional group) will be considered in the statistical analysis and the rate of&#xD;
      non-adherent participants will be mentioned in the results.Correlations between the&#xD;
      realization and the quality of home BP monitoring in MD consultation and controlled BP will&#xD;
      also be analyzed. No interim analyses are scheduled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 1, 2023</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of controlled blood pressure in MD consultation (office blood pressure &lt; 140/90 mmHg)</measure>
    <time_frame>12 months</time_frame>
    <description>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 &lt; 140 mmHg and diastolic blood pressure &lt; 90 mmHg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of home blood pressure monitoring brought to MD consultation</measure>
    <time_frame>12 months</time_frame>
    <description>According to the 2020 International Society of Hypertension (ISH) Global Hypertension Practice Guidelines, the protocol for home BP monitoring will be: 3-day monitoring with a cycle of 3 measures every morning and every evening at one-minute intervals, in a sitting position, after 5 minutes of rest and before meals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of the home blood pressure monitoring brought to MD consultation</measure>
    <time_frame>12 months</time_frame>
    <description>The quality will be assessed by the number of measurements (18 measurements over 3 days according to the protocol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of therapeutic adjustments during the APN intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Rate of therapeutic adjustments among the interventional group during the APN intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication(s) of therapeutic adjustments during the APN intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Rate of therapeutic adjustments due to lack of efficacy and/or intolerance among the interventional group during the APN intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in rates of controlled blood pressure (office blood pressure &lt; 140/90 mmHg) between day hospitalization and MD consultation in each group.</measure>
    <time_frame>12 months</time_frame>
    <description>Evolution of the rate of controlled blood pressure between day hospitalization and MD consultation in each group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group of patients keeps a traditional follow-up: day hospitalization then consultation with a MD within two to twelve months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>APN intervention</intervention_name>
    <description>APN intervention is divided into five main steps:&#xD;
clinical and paraclinical examinations,&#xD;
appraisal of patient's knowledge,&#xD;
health education on hypertension and treatments,&#xD;
setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary,&#xD;
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.</description>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years of age,&#xD;
&#xD;
          -  treated or untreated hypertension,&#xD;
&#xD;
          -  can to provide a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years old,&#xD;
&#xD;
          -  inability to give a free informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliette VAY-DEMOUY</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juliette VAY-DEMOUY</last_name>
    <phone>0142348551</phone>
    <email>juliette.vaydemouy@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jacques BLACHER</last_name>
    <phone>0142348966</phone>
    <email>jacques.blacher@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Hôtel-Dieu</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Juliette VAY-DEMOUY</last_name>
      <phone>0142348551</phone>
      <email>juliette.vaydemouy@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Jacques BLACHER</last_name>
      <phone>0142348966</phone>
      <email>jacques.blacher@aphp.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hotel Dieu University Hospital, France</investigator_affiliation>
    <investigator_full_name>Jacques Blacher</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Advanced Pratice Nurse</keyword>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448249
org study id: APN
nct id: NCT04448249
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)
time frame: 12 months
description: 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.
measure: Rate of home blood pressure monitoring brought to MD consultation
time frame: 12 months
description: According to the 2020 International Society of Hypertension (ISH) Global Hypertension Practice Guidelines, the protocol for home BP monitoring will be: 3-day monitoring with a cycle of 3 measures every morning and every evening at one-minute intervals, in a sitting position, after 5 minutes of rest and before meals.
measure: Quality of the home blood pressure monitoring brought to MD consultation
time frame: 12 months
description: The quality will be assessed by the number of measurements (18 measurements over 3 days according to the protocol).
measure: Rate of therapeutic adjustments during the APN intervention
time frame: 6 months
description: Rate of therapeutic adjustments among the interventional group during the APN intervention.
measure: Indication(s) of therapeutic adjustments during the APN intervention
time frame: 6 months
description: Rate of therapeutic adjustments due to lack of efficacy and/or intolerance among the interventional group during the APN intervention.
measure: Difference in rates of controlled blood pressure (office blood pressure < 140/90 mmHg) between day hospitalization and MD consultation in each group.
time frame: 12 months
description: Evolution of the rate of controlled blood pressure between day hospitalization and MD consultation in each group.
arm group label: Interventional group
arm group type: Experimental
description: 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
arm group label: Control group
arm group type: No Intervention
description: The control group of patients keeps a traditional follow-up: day hospitalization then consultation with a MD within two to twelve months
intervention type: Behavioral
intervention name: APN intervention
description: 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.
arm group label: Interventional group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juliette VAY-DEMOUY
role: Principal Investigator
affiliation: Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France
last name: Juliette VAY-DEMOUY
phone: 0142348551
email: juliette.vaydemouy@aphp.fr
last name: Jacques BLACHER
phone: 0142348966
email: jacques.blacher@aphp.fr
facility: 
contact: 
contact backup: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hotel Dieu University Hospital, France
investigator full name: Jacques Blacher
investigator title: MD, PhD
mesh term: Hypertension