A Multicenter Randomized Clinical Trial Aimed at Evaluating the Effectiveness of Self-care Promotion in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 704
- 试验地点
- 1
- 主要终点
- The evaluation of the effect of multifaceted intervention compared to usual outpatient care on the primary endpoint will be performed using the Student's t-Student test of the log ratio of NT-proBNP levels at 6 months baseline.
研究概览
简要总结
Study Design: A randomized, multicenter, national, phase II clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(SMS)to patients with heart failure.
Methodological quality:
- Central randomization with allocation concealment;
- Decision committee for blind outcome assessment;
- Intention-to-treat analysis
详细描述
Study Design -A randomized, multicenter, national, phase II clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(SMS) to patients with heart failure.
Methodological quality
-Central randomization with allocation concealment; Decision committee for blind outcome assessment; Intention-to-treat analysis
Primary Objective -To develop and evaluate the feasibility of a monitoring, education and self-care strategy to optimize the management of patients with heart failure (HF) after hospital discharge.
Secondary Objectives
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
- Single (Outcomes Assessor)
盲法说明
Experimental group:
-Self-care promotion using a multifaceted strategy based on the use of a tele-monitoring device, based on short message system (SMS) messages and self-care teaching tools.
Patients will receive daily messages to optimize self-care in heart failure with the following functions:
- customized reminders about medication schedules
- weight and symptoms of decompensation monitoring assessing a decision tree with diuretics adjustment if needed and alerts that define the need to contact a health professional for early intervention before deterioration of the clinical state, identifying situations that require clinical intervention.
- educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)
- diary for registration of visits to health services and clinical setting.
Control group:
-Usual outpatient care
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
- •Adults (> 18 years)
- •Heart failure of any etiology
- •Vulnerable period after episode of acute decompensation
- •Cellular telephony acess;
- •Left Ventricular Ejection Fraction (LVEF <40%),
排除标准
- •Cardiac transplant wait list;
- •Surgical or percutaneous (coronary or valvular) treatment at last 3 months
- •HF terminal ;
- •Life expectancy <1 year;
- •Another drug or device study at last 30 days
- •Prior randomization in the study
研究组 & 干预措施
self-care promotion
multifaceted strategy based on sending text messages(SMS) to patients with heart failure.
Press educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity).
The text messages are about how the patient should take your drugs (evem diuretics), measure blood pressure and weight in Kg, and about signals and symptoms (shorthbreathness during the night), and about how important is practice physical exercises and don't drink alcohol.
干预措施: Multifaceted strategy based on sending text messages(SMS) (Other)
Control group
routinely management in the HF. Press educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)
干预措施: Usual outpatient care (Other)
结局指标
主要结局
The evaluation of the effect of multifaceted intervention compared to usual outpatient care on the primary endpoint will be performed using the Student's t-Student test of the log ratio of NT-proBNP levels at 6 months baseline.
时间窗: six months
Variation of NT-proBNP in 180 days;
次要结局
- Overall mortality(Six months)
- Overall hospitalization(Six months)
- Cardiovascular mortality(Six months)
- Emergency department visit(Six months)
- Satisfaction of the patient and / or caregiver with health care(Thirty days)
- Acceptability / adherence to the system of sending messages(Six months)
- Variation of NT-proBNP in 30 days(30 days)
- Kansas Health-related quality of life in baseline, 30 and 180 days(From baseline, 30 and 180 days.)
- Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea.(Baseline, 30, 90 and 180 days visits)
- European Heart Failure Self-Care Behavior Scale - EHFScBs(From 30 and 180 days.)
- Heart Failure Knowledge Questionnaire(From 30 and 180 days.)