About The Clinical Trial
Trial Name: Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients (IC-CBC)
ClinicalTrials.gov ID: NCT04062461
Sponsor: Hospital do Coracao
Completion Date: January 2023
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Study: Telemonitoring After Heart Failure Comparable to Standard of Care
Individuals received 4 daily short messages that reminding them to participate in self-care, active engagement, and early intervention for the first 30 days of the study.
Intensive telemonitoring during the vulnerable period after a heart failure (HF) hospital admission increased scores of HF self-care; however, investigators found that it did not lead to reductions in N-terminal pro–brain natriuretic peptide (NT-proBNP) levels nor improvements in composite hierarchical clinical outcomes, according to results of a study published in JAMA Cardiology.
Investigators of the study aimed to determine whether an intensive telemonitoring strategy was efficacious and feasible for individuals after an HF hospitalization. The study was conducted in Brazil and included 30 HF clinics. According to the study authors, patients who had left ventricular ejection fraction (LVEF) less than 40% and had access to a mobile phone were enrolled up to 30 days after HF admission. Data were gathered from July 2019 to July 2022.
As part of the telemonitoring, individuals received 4 daily short messages that reminded them to participate in self-care, active engagement, and early intervention for the first 30 days, according to the study investigators. After the 30 days, the text messages could be reduced to 3 times a week for stable patients. Further, feedback messages that indicated warnings triggered an automatic diuretic adjustment and/or a telephone call from the health care team. Warnings included rapid weight gain, dyspnea, lack of patient-reported adherence, and others. For the standard of care, the individual institution provided recommendations at discharge or at the randomization visit, according to the study.
The primary endpoint was change in NT-proBNP from baseline to 180 days while the hierarchical win-ratio analysis of clinical events, including cardiovascular deaths and HF hospitalization, and variation in NT-proBNP were measured.
Investigators included 699 individuals in the study, with 352 being assigned to telemonitoring and 347 to the standard of care Approximately 65.8% were male and the mean age was 61.2 years, according to the study authors. Most individuals had nonischemic etiology, with the median LVEF being 28%. LVEF was 30% or less in 64.2% of individuals.
The study authors reported that there were no statistical differences between the 2 groups. Further, in the hierarchical analysis, the total number of wins for the telemonitoring group was 40.8% compared to the standard of care at 39.3%, according to the results. Investigators said there were no meaningful differences observed in individual tiers.
Additionally, the study authors said that in the telemonitoring group, the mean score for the European Heart Failure Self-Care Behavior scale was lower, indicating better self-care, at 30 days compared to in the standard of care group, with scores of 22.4 and 24.7, respectively. At 180 days, the benefit was maintained in the telemonitoring group. Self-care measures that improved the scores were related to daily weight, amount of daily fluid intake, adherence to medication, and vaccination against influenza, according to the results.
Warnings in the telemonitoring group during the first 30 days included 19.9% feeling breathless overnight for 2 consecutive days, 3% reported inadequate use of medications in 2 consecutive days, and 31.5% with reported body weight change. Overall, there were 249 telephone calls made to 110 individuals, with an 82.2% success rate. Automatic furosemide adjustments were made for 12.2% of patients, according to the study results. Reasons for lack of interaction with SMS systems included forgetfulness to answer (31.4%), technical issues (24%), lack of time (15.4%), and lack of knowledge about how to answer (5.7%), according to the study investigators.
Investigators reported that there were no major concerns related to safety with the telemonitoring intervention.
Reference
Rohde LE, Rover MM, Hoffmann Filho CR, Rabelo-Silva ER, et al. Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial. JAMA Cardiol. 2023. doi:10.1001/jamacardio.2023.4501
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