Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients
- Conditions
- Heart Failure
- Interventions
- Other: Multifaceted strategy based on sending text messages(SMS)Other: Usual outpatient care
- Registration Number
- NCT04062461
- Lead Sponsor
- Hospital do Coracao
- Brief 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
- Detailed 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 704
- Adults (> 18 years)
- Heart failure of any etiology
- Vulnerable period after episode of acute decompensation
- Cellular telephony acess;
- Left Ventricular Ejection Fraction (LVEF <40%),
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description self-care promotion Multifaceted strategy based on sending text messages(SMS) 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. Control group Usual outpatient care 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)
- Primary Outcome Measures
Name Time Method 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. six months Variation of NT-proBNP in 180 days;
- Secondary Outcome Measures
Name Time Method Overall mortality Six months Overall mortality for Heart Failure at 180 days
Overall hospitalization Six months Overall hospitalization for Heart Failure at 180 days
Cardiovascular mortality Six months To evaluate cardiovascular mortality in 180 days
Emergency department visit Six months To evaluate emergency department visit in 180 days
Satisfaction of the patient and / or caregiver with health care Thirty days 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.
Acceptability / adherence to the system of sending messages Six months 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.
Variation of NT-proBNP in 30 days 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.
Kansas Health-related quality of life in baseline, 30 and 180 days From 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.
Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea. Baseline, 30, 90 and 180 days visits 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.
European Heart Failure Self-Care Behavior Scale - EHFScBs From 30 and 180 days. 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.
Heart Failure Knowledge Questionnaire From 30 and 180 days. Used to measure Knowledge about Heart Failure. Are by 14 questions more than 70% of correct answers means good Knowledge.
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil