Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 125
- 试验地点
- 32
- 主要终点
- Evaluation of the use of "MonCoeur" application on the impact of patient health self-care
研究概览
简要总结
Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.
详细描述
The aim of this study is to demonstrate that the use of a special application dedicated to the monitoring of heart failures disease has a favorable impact on the occurrence of readmissions and, ultimately, cardiovascular mortality. The aim of this study is also to demonstrate that the use of this "MonCœur" application improves symptoms, quality of life, treatment compliance, diet compliance, and physical activity in patient with heart failure disease.
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
- •Patient hospitalized for acute or decompensated heart failure
- •Patient with a smartphone and able to use a digital application
- •Beneficiary of a social protection scheme
- •Patients benefiting from a telemedicine program can be included
排除标准
- •Acute coronary syndrome during ongoing hospitalization.
- •Acute myocarditis, constrictive pericarditis, acute endocarditis during ongoing hospitalization.
- •Isolated right heart failure of respiratory origin.
- •Existence of a cause considered rapidly reversible to acute heart failure: tachyarrhythmia, excessive bradycardia, acute anemia, acute renal failure, malignant hypertension, overdose or cardiotoxic drug intoxication.
- •Indication of cardiac surgery scheduled within 3 months after hospitalization, patients with Tavi or MItraclip expected within 3 months
- •Extracardiac disease with short-term prognosis (progressive neoplasia).
- •Refusal or incapacitation of language or psychic to sign informed consent
- •Patients participating in an other biomedical research can not participate in this study for the first 6 months, not to interfere with the consultation process of the study.
- •Pregnant or lactating women can't participate in the study.
结局指标
主要结局
Evaluation of the use of "MonCoeur" application on the impact of patient health self-care
时间窗: 3, 6 and 12 months
Comparison between the 2 study arms of the score of the European Heart Failure Self-care Behaviour Scale, consisting of 9 items each evaluated on a 5-point Likert scale, and allowing the calculation of a standardized global score from 0 to 100: the highest score indicating better "self-care".
次要结局
- Evaluation of the use of "MonCoeur" application on patient compliance(3, 6 and 12 months)
- Evaluation of the use of "MonCoeur" application on patient physical activity(3, 6 and 12 months)
- Evaluation of the use of "MonCoeur" application on hospitalisation rate(3, 6 and 12 months)
- Describe how often and how the application is used by patients(3, 6 and 12 months)
- Evaluation of the use of "MonCoeur" application on cardiovascular parameters(3, 6 and 12 months)
- Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire(3, 6 and 12 months)