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

Study Overview
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Brief Summary
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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

Detailed Description
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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)

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Multifaceted strategy based on sending text messages(SMS)
* Other: Usual outpatient care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-care promotion<br>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. | Other: Multifaceted strategy based on sending text messages(SMS)<br>* 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.<br>|
| Active Comparator: Control group<br>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) | Other: Usual outpatient care<br>* Educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Variation of NT-proBNP in 180 days; | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Overall mortality for Heart Failure at 180 days | Six months | 
| Overall hospitalization | Overall hospitalization for Heart Failure at 180 days | Six months | 
| Cardiovascular mortality | To evaluate cardiovascular mortality in 180 days | Six months | 
| Emergency department visit | To evaluate emergency department visit in 180 days | Six months | 
| Satisfaction of the patient and / or caregiver with health care | Using (NPS tool):Scale of 0-10 to measure satisfaction of the patient and / or caregiver with health care. Rate it from 0 to 10, where 0 means not at all satisfied and 10 means extremely satisfied. | Thirty days | 
| Acceptability / adherence to the system of sending messages | Using a Scale of 0-10 (question to insert the note) to measure acceptability / adherence to the system of sending messages. Rate it from 0 to 10, where 0 means no help at all and 10 means the posts were extremely beneficial. | Six months | 
| Variation of NT-proBNP in 30 days | 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 30 days from baseline. | 30 days | 
| Kansas Health-related quality of life in baseline, 30 and 180 days | Using (Kansas Health-related quality of life Questionnaire): Scale of 0-100 to measure quality of life in patients with heart failure. Rate it from 0 to 100. Overall score means higher is better. | From baseline, 30 and 180 days. | 
| Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea. | Using Variation scale numeric of VAS (Visual Analogue Scale) to measure degree of dyspnea. Rate from 0 to 10, where 0 means no dyspnea and 10 the highest complain of dyspnea. | Baseline, 30, 90 and 180 days visits | 
| European Heart Failure Self-Care Behavior Scale - EHFScBs | Using (EHFScBs): Scale of 0-60 to to measure self-care behavior of heart failure (HF) patients. Rate it from 0 to 60. Overall score means smaller is better. | From 30 and 180 days. | 
| Heart Failure Knowledge Questionnaire | Used to measure Knowledge about Heart Failure. Are by 14 questions more than 70% of correct answers means good Knowledge. | From 30 and 180 days. |