Therapeutic Education Strategy for Patients With Acute Heart Failure
关键词
抽象
描述
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.
日期
| 最后验证: | 12/31/2018 |
| 首次提交: | 12/04/2016 |
| 提交的预估入学人数: | 01/24/2017 |
| 首次发布: | 01/26/2017 |
| 上次提交的更新: | 01/29/2019 |
| 最近更新发布: | 01/30/2019 |
| 实际学习开始日期: | 03/31/2017 |
| 预计主要完成日期: | 12/29/2020 |
| 预计完成日期: | 12/29/2020 |
状况或疾病
干预/治疗
Behavioral: Interventional
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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. | Behavioral: Interventional Interventional arm |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Number of rehospitalizations for acute heart failure (HF) in both groups of patients [1 year]
次要成果指标
1. Patients knowledge about the illness [1 year]
2. Global quality of life [1 year]
3. Quality of life linked to Heart Failure [1 year]
4. Length of stay for HF and all-cause hospitalizations [1 year of follow-up]
5. Hospitalization rate for cardiovascular diseases except HF [1 year of follow-up]
6. Cardiovascular and all-cause mortality rate [1 year of follow-up]
7. B-type natriuretic peptide (BNP) or NT pro-BNP levels [During 1 year of follow-up]
其他成果措施
1. Cost effectiveness of the intervention [During 1 year of follow-up]
