<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/NCT03035123</url>
  </required_header>
  <id_info>
    <org_study_id>EduStra-HF</org_study_id>
    <secondary_id>RCB ID: 2016-A00899-42</secondary_id>
    <nct_id>NCT03035123</nct_id>
  </id_info>
  <brief_title>Therapeutic Education Strategy for Patients With Acute Heart Failure</brief_title>
  <acronym>EduStra-HF</acronym>
  <official_title>Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Resicard</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence Regionale de Sante d'Ile de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>French Cardiology Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Resicard</source>
  <oversight_info>
    <has_dmc>No</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>
      The EduStra-HF study will examine the impact of an intensive therapeutic education on&#xD;
      patients discharged from hospital after an episode of acute heart failure (HF).&#xD;
&#xD;
      Patients will be randomized into two groups: one will receive &quot;usual care&quot; monitoring and one&#xD;
      will receive a specific educational monitoring programme for 1 year.&#xD;
&#xD;
      All patients will meet with a specialized therapeutic education nurse before discharge.&#xD;
&#xD;
      The effect of the intensive education on HF rehospitalization and quality of life will be&#xD;
      examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of HF in France is increasing. According to a report from the Haute Autorité&#xD;
      de Santé (HAS) - the French Health Authority - published in June 2015 concerning discharge of&#xD;
      patients hospitalized for HF, 2.3% of the French adult population is affected. Despite&#xD;
      improvements in treatment and HF-specific care, the rehospitalization rate for HF remains&#xD;
      substantial, and HF management is a major public health issue.&#xD;
&#xD;
      Chronic HF leads to psychological and physiological issues in patients. Furthermore, this&#xD;
      disease affects patient quality of life and activities of daily living.&#xD;
&#xD;
      The HAS also reported that even if iterative hospitalizations are the consequence of&#xD;
      complicated and multifactorial situations, some could be prevented by improved patient care.&#xD;
&#xD;
      The aim of the EduStra-HF study is to examine the effect of an intensive therapeutic&#xD;
      education on patients discharged from hospital after an episode of acute HF. It will study&#xD;
      whether this intervention reduces the rate of rehospitalization and increases quality of life&#xD;
      in this population.&#xD;
&#xD;
      To achieve this goal, a multicentre, randomized, two parallel arm study will be conducted.&#xD;
      Patients will be included in several cardiology centres in Paris (Ile-de-France) over 2 years&#xD;
      and 3 months.&#xD;
&#xD;
      Included patients, chosen from patients admitted for acute HF in the participating hospitals,&#xD;
      will be randomized into two groups, which will determine the monitoring they receive after&#xD;
      discharge. For each patient, monitoring will last for 1 year from the day they return home.&#xD;
&#xD;
      The first group of patients will be randomized to receive &quot;usual care&quot; monitoring and will&#xD;
      not be given specific therapeutic education after discharge.&#xD;
&#xD;
      The second group (intervention arm) will receive a specific educational monitoring programme&#xD;
      from nurses via telephone calls and home visits, for 1 year. Monitoring will began early&#xD;
      after discharge. Annual medical monitoring and visits to the cardiologist will also be&#xD;
      planned.&#xD;
&#xD;
      All patients, regardless of attribution arm, will meet a nurse trained in therapeutic&#xD;
      education during their stay in hospital. Moreover, validated and HF-related self-assessed&#xD;
      questionnaires will be analyzed to assess quality of life and impact of HF on patient&#xD;
      activities of daily living.&#xD;
&#xD;
      In the interventional arm, patients will receive monitoring documents, such as a HF&#xD;
      information booklet and a personal monitoring agenda.&#xD;
&#xD;
      The EduStra-HF study will provide a specific analysis of a multisupport therapeutic education&#xD;
      (including medical monitoring). Data on all HF drug treatments, including the more recent&#xD;
      ones (e.g. Entresto), blood tests results, and cardiologic data will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of rehospitalizations for acute heart failure (HF) in both groups of patients</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients knowledge about the illness</measure>
    <time_frame>1 year</time_frame>
    <description>Nurses will evaluate during each telephone call and home visit patients knowledge and skills about the following items : illness, treatments, diet, physical activity, medical follow-up. This data will be recorded in a specific table and classified into &quot;acquired / partially acquired / not acquired&quot; items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed by validated questionnaire SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life linked to Heart Failure</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed by validated questionnaire KCCQ-15</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay for HF and all-cause hospitalizations</measure>
    <time_frame>1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization rate for cardiovascular diseases except HF</measure>
    <time_frame>1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular and all-cause mortality rate</measure>
    <time_frame>1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B-type natriuretic peptide (BNP) or NT pro-BNP levels</measure>
    <time_frame>During 1 year of follow-up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost effectiveness of the intervention</measure>
    <time_frame>During 1 year of follow-up</time_frame>
    <description>Comparison between both groups of patients of the HF-hospitalizations average cost, related to the operating cost of the EduStra-HF method.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1086</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>&quot;Usual care&quot;</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will attend an appointment with the therapeutic education nurse before discharge, after which they will have no further contact with the education team. The Research team members will telephone the patient three times during the year (after 2, 6 and 12 months) to collect data on HF treatments, blood tests results, health-related events and hospitalizations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before discharge, patients will attend an appointment with a nurse trained in therapeutic education, in which the nurse will evaluate the overall knowledge and the skills of the patient about HF. The nurse will then define specific educational objectives with the patient, based on the patient's medical history, state of disease, comorbidities, alarm signs, fears and knowledge.&#xD;
Each patient will receive six telephone calls and two home-visits during the 1 year of follow-up. Each contact between the nurse and the patient will be dedicated to HF education. The patient will also receive regular short text messages containing health advice and appointment reminders.&#xD;
To help the patient regain his/her autonomy, intervals between education sessions will be progressively longer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapeutic education</intervention_name>
    <description>Interventional arm</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient with acute HF&#xD;
&#xD;
          -  Affiliated to the French Social Security system&#xD;
&#xD;
          -  Accepting the principle of telephone monitoring&#xD;
&#xD;
          -  Accepting home visits from a study nurse&#xD;
&#xD;
          -  Possession of a mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Psychosocial:&#xD;
&#xD;
          -  Refusal to accept the study design&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Monitoring obstacle: language, cognitive deficiency, itinerant lifestyle, regular&#xD;
             travel, institutionalization&#xD;
&#xD;
          -  Inability to sign the consent form or to complete questionnaires&#xD;
&#xD;
        Medical:&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Severe psychiatric or neurological disorder&#xD;
&#xD;
          -  Complicated acute myocardial infarction&#xD;
&#xD;
          -  Significant valvular diseases requiring surgery&#xD;
&#xD;
          -  Hypertrophic obstructive cardiomyopathy&#xD;
&#xD;
          -  Planned heart transplant&#xD;
&#xD;
          -  Cardiac surgery in the previous 3 months&#xD;
&#xD;
          -  Enrollment in another clinical trial&#xD;
&#xD;
          -  Medical or surgical procedure which might interfere with monitoring&#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>Ariel Cohen, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Saint-Antoine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ariel Cohen, MD PhD</last_name>
    <phone>+33149282886</phone>
    <email>ariel.cohen@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrick Assyag, MD</last_name>
    <phone>+33143798361</phone>
    <email>patrick.assyag@wanadoo.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinique Ambroise Paré</name>
      <address>
        <city>Neuilly-sur-Seine</city>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Clinique du Mont Louis</name>
      <address>
        <city>Paris</city>
        <zip>75011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Hopital AP-HP Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ariel Cohen, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital AP-HP Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Centre Cardiologique du Nord</name>
      <address>
        <city>Saint Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Thierry Laperche, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier André Mignot</name>
      <address>
        <city>Versailles</city>
        <zip>78000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jean-Louis George, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.has-sante.fr/portail/upload/docs/application/pdf/2015-06/note_methodo_synthese_documentaire_ic_web.pdf</url>
    <description>Haute Autorité de Santé (HAS). Note méthodologique et de synthèse documentaire : Comment organiser la sortie des patients hospitalisés pour insuffisance cardiaque ? Points clés - Organisation des parcours. April 2015 - Accessed on 1 December 2016</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Antoine University Hospital</investigator_affiliation>
    <investigator_full_name>Pr Ariel Cohen</investigator_full_name>
    <investigator_title>Head of the cardiology department</investigator_title>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Therapeutic education</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Sharing Individual Participant Data requires a specific authorization from the French Board CNIL (Commission Nationale de l'Informatique et des Libertés) which chooses whether to allow the research team to share patient data. A specific request is needed and will be sent to that authority.</ipd_description>
  </patient_data>
  <!-- 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/NCT03035123
org study id: EduStra-HF
secondary id: RCB ID: 2016-A00899-42
nct id: NCT03035123
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The EduStra-HF study will examine the impact of an intensive therapeutic education on
      patients discharged from hospital after an episode of acute heart failure (HF).

      Patients will be randomized into two groups: one will receive "usual care" monitoring and one
      will receive a specific educational monitoring programme for 1 year.

      All patients will meet with a specialized therapeutic education nurse before discharge.

      The effect of the intensive education on HF rehospitalization and quality of life will be
      examined.
The prevalence of HF in France is increasing. According to a report from the Haute Autorité
      de Santé (HAS) - the French Health Authority - published in June 2015 concerning discharge of
      patients hospitalized for HF, 2.3% of the French adult population is affected. Despite
      improvements in treatment and HF-specific care, the rehospitalization rate for HF remains
      substantial, and HF management is a major public health issue.

      Chronic HF leads to psychological and physiological issues in patients. Furthermore, this
      disease affects patient quality of life and activities of daily living.

      The HAS also reported that even if iterative hospitalizations are the consequence of
      complicated and multifactorial situations, some could be prevented by improved patient care.

      The aim of the EduStra-HF study is to examine the effect of an intensive therapeutic
      education on patients discharged from hospital after an episode of acute HF. It will study
      whether this intervention reduces the rate of rehospitalization and increases quality of life
      in this population.

      To achieve this goal, a multicentre, randomized, two parallel arm study will be conducted.
      Patients will be included in several cardiology centres in Paris (Ile-de-France) over 2 years
      and 3 months.

      Included patients, chosen from patients admitted for acute HF in the participating hospitals,
      will be randomized into two groups, which will determine the monitoring they receive after
      discharge. For each patient, monitoring will last for 1 year from the day they return home.

      The first group of patients will be randomized to receive "usual care" monitoring and will
      not be given specific therapeutic education after discharge.

      The second group (intervention arm) will receive a specific educational monitoring programme
      from nurses via telephone calls and home visits, for 1 year. Monitoring will began early
      after discharge. Annual medical monitoring and visits to the cardiologist will also be
      planned.

      All patients, regardless of attribution arm, will meet a nurse trained in therapeutic
      education during their stay in hospital. Moreover, validated and HF-related self-assessed
      questionnaires will be analyzed to assess quality of life and impact of HF on patient
      activities of daily living.

      In the interventional arm, patients will receive monitoring documents, such as a HF
      information booklet and a personal monitoring agenda.

      The EduStra-HF study will provide a specific analysis of a multisupport therapeutic education
      (including medical monitoring). Data on all HF drug treatments, including the more recent
      ones (e.g. Entresto), blood tests results, and cardiologic data will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of rehospitalizations for acute heart failure (HF) in both groups of patients
time frame: 1 year
measure: Patients knowledge about the illness
time frame: 1 year
description: Nurses will evaluate during each telephone call and home visit patients knowledge and skills about the following items : illness, treatments, diet, physical activity, medical follow-up. This data will be recorded in a specific table and classified into "acquired / partially acquired / not acquired" items.
measure: Global quality of life
time frame: 1 year
description: Assessed by validated questionnaire SF-12
measure: Quality of life linked to Heart Failure
time frame: 1 year
description: Assessed by validated questionnaire KCCQ-15
measure: Length of stay for HF and all-cause hospitalizations
time frame: 1 year of follow-up
measure: Hospitalization rate for cardiovascular diseases except HF
time frame: 1 year of follow-up
measure: Cardiovascular and all-cause mortality rate
time frame: 1 year of follow-up
measure: B-type natriuretic peptide (BNP) or NT pro-BNP levels
time frame: During 1 year of follow-up
measure: Cost effectiveness of the intervention
time frame: During 1 year of follow-up
description: Comparison between both groups of patients of the HF-hospitalizations average cost, related to the operating cost of the EduStra-HF method.
arm group label: "Usual care"
arm group type: No Intervention
description: Patients will attend an appointment with the therapeutic education nurse before discharge, after which they will have no further contact with the education team. The Research team members will telephone the patient three times during the year (after 2, 6 and 12 months) to collect data on HF treatments, blood tests results, health-related events and hospitalizations.
arm group label: Interventional
arm group type: Experimental
description: Before discharge, patients will attend an appointment with a nurse trained in therapeutic education, in which the nurse will evaluate the overall knowledge and the skills of the patient about HF. The nurse will then define specific educational objectives with the patient, based on the patient's medical history, state of disease, comorbidities, alarm signs, fears and knowledge.
Each patient will receive six telephone calls and two home-visits during the 1 year of follow-up. Each contact between the nurse and the patient will be dedicated to HF education. The patient will also receive regular short text messages containing health advice and appointment reminders.
To help the patient regain his/her autonomy, intervals between education sessions will be progressively longer.
intervention type: Behavioral
intervention name: Therapeutic education
description: Interventional arm
arm group label: Interventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ariel Cohen, MD PhD
role: Principal Investigator
affiliation: Hôpital Saint-Antoine
last name: Ariel Cohen, MD PhD
phone: +33149282886
email: ariel.cohen@aphp.fr
last name: Patrick Assyag, MD
phone: +33143798361
email: patrick.assyag@wanadoo.fr
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
investigator: 
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: France
url: http://www.has-sante.fr/portail/upload/docs/application/pdf/2015-06/note_methodo_synthese_documentaire_ic_web.pdf
description: Haute Autorité de Santé (HAS). Note méthodologique et de synthèse documentaire : Comment organiser la sortie des patients hospitalisés pour insuffisance cardiaque ? Points clés - Organisation des parcours. April 2015 - Accessed on 1 December 2016
responsible party type: Principal Investigator
investigator affiliation: Saint Antoine University Hospital
investigator full name: Pr Ariel Cohen
investigator title: Head of the cardiology department
mesh term: Heart Failure
sharing ipd: Undecided
ipd description: Sharing Individual Participant Data requires a specific authorization from the French Board CNIL (Commission Nationale de l'Informatique et des Libertés) which chooses whether to allow the research team to share patient data. A specific request is needed and will be sent to that authority.