Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 6
- 主要终点
- Number of rehospitalizations for acute heart failure (HF) in both groups of patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
"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.
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.
干预措施: Therapeutic education (Behavioral)
结局指标
主要结局
Number of rehospitalizations for acute heart failure (HF) in both groups of patients
时间窗: 1 year
次要结局
- Quality of life linked to Heart Failure(1 year)
- Hospitalization rate for cardiovascular diseases except HF(1 year of follow-up)
- Cardiovascular and all-cause mortality rate(1 year of follow-up)
- B-type natriuretic peptide (BNP) or NT pro-BNP levels(During 1 year of follow-up)
- Global quality of life(1 year)
- Patients knowledge about the illness(1 year)
- Length of stay for HF and all-cause hospitalizations(1 year of follow-up)
研究者
Pr Ariel Cohen
Head of the cardiology department
Saint Antoine University Hospital