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

Hospital do Coracao

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Other: Usual outpatient care; Other: Multifaceted strategy based on sending text messages(SMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04062461

01

Details and patient eligibility

About

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

Full 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)

Enrollment: 704 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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704 participants in 2 patient groups

self-care promotion

Experimental group

Description:

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.

Treatment:

Other: Multifaceted strategy based on sending text messages(SMS)

Control group

Active Comparator group

Description:

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)

Treatment:

Other: Usual outpatient care