Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients

A Multicenter Randomized Clinical Trial Aimed at Evaluating the Effectiveness of Self-care Promotion in Patients With Heart Failure

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

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

-To evaluate, in patients with heart failure, the effect of a self-care promotion program using a multifaceted strategy in comparison to the usual care about acceptability to the application of SMS, patient and / or family satisfaction with care, quality of life scales health scales, self-care scales and knowledge on HF, visual analog scale of dyspnea, and clinical outcomes at 30 and 180 days.

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

Follow-up

• Follow up will be at least 180 days from the inclusion in the study.
• Sample size estimation 350 patients per group (700 patients)

Inclusion Criteria:

• Adults (> 18 years)
• Heart failure of any etiology
• Vulnerable period after episode of acute decompensation
• Cellular telephony acess;
• Left Ventricular Ejection Fraction (LVEF <40%),

Exclusion Criteria:

• 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