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

Heart Failure Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT04062461
• Study type: Interventional
• Source: Hospital do Coracao
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2019
• Completion date: April 30, 2023