Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Therapeutic Education Strategy for Patients With Acute Heart Failure (EduStra-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035123
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
Agence Regionale de Sante d'Ile de France
Assistance Publique - Hôpitaux de Paris
French Cardiology Society
Novartis
Information provided by (Responsible Party):
Pr Ariel Cohen, Saint Antoine University Hospital

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Number of rehospitalizations for acute heart failure (HF) in both groups of patients [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03035123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Patients knowledge about the illness [ Time Frame: 1 year ]
    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.
  • Global quality of life [ Time Frame: 1 year ]
    Assessed by validated questionnaire SF-12
  • Quality of life linked to Heart Failure [ Time Frame: 1 year ]
    Assessed by validated questionnaire KCCQ-15
  • Length of stay for HF and all-cause hospitalizations [ Time Frame: 1 year of follow-up ]
  • Hospitalization rate for cardiovascular diseases except HF [ Time Frame: 1 year of follow-up ]
  • Cardiovascular and all-cause mortality rate [ Time Frame: 1 year of follow-up ]
  • B-type natriuretic peptide (BNP) or NT pro-BNP levels [ Time Frame: During 1 year of follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2017)
Cost effectiveness of the intervention [ Time Frame: During 1 year of follow-up ]
Comparison between both groups of patients of the HF-hospitalizations average cost, related to the operating cost of the EduStra-HF method.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Therapeutic Education Strategy for Patients With Acute Heart Failure
Official Title  ICMJE Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure
Intervention  ICMJE Behavioral: Therapeutic education
Interventional arm
Study Arms  ICMJE
  • No Intervention: "Usual care"
    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.
  • Experimental: Interventional

    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: Behavioral: Therapeutic education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
1086
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patient with acute HF
  • Affiliated to the French Social Security system
  • Accepting the principle of telephone monitoring
  • Accepting home visits from a study nurse
  • Possession of a mobile phone

Exclusion Criteria:

Psychosocial:

  • Refusal to accept the study design
  • Patient under guardianship
  • Monitoring obstacle: language, cognitive deficiency, itinerant lifestyle, regular travel, institutionalization
  • Inability to sign the consent form or to complete questionnaires

Medical:

  • Active cancer
  • Severe psychiatric or neurological disorder
  • Complicated acute myocardial infarction
  • Significant valvular diseases requiring surgery
  • Hypertrophic obstructive cardiomyopathy
  • Planned heart transplant
  • Cardiac surgery in the previous 3 months
  • Enrollment in another clinical trial
  • Medical or surgical procedure which might interfere with monitoring
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ariel Cohen, MD PhD +33149282886 ariel.cohen@aphp.fr
Contact: Patrick Assyag, MD +33143798361 patrick.assyag@wanadoo.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035123
Other Study ID Numbers  ICMJE EduStra-HF
RCB ID: 2016-A00899-42 ( Other Grant/Funding Number: National Drug and Health Products Safety Agency (ANSM) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan 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.
Responsible Party Pr Ariel Cohen, Saint Antoine University Hospital
Study Sponsor  ICMJE Resicard
Collaborators  ICMJE
  • Agence Regionale de Sante d'Ile de France
  • Assistance Publique - Hôpitaux de Paris
  • French Cardiology Society
  • Novartis
Investigators  ICMJE
Principal Investigator: Ariel Cohen, MD PhD Hôpital Saint-Antoine
PRS Account Resicard
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP