Heart Failure Heart Diseases
Conditions
Interventions
This is a randomized-controlled, superiority, multicenter clinical trial, with two parallel arms and allocation ratio 1:1, blinded to outcome assessment due to the nature of the intervention (digital
b) Vital data/Weight, measured by the patient daily and sent to the Telehealth Center of the Hospital das Clínicas of UFMG (CTS-HC)
and c) Quality of current clinical treatment in relation to ideal treatment. In addition, the application offers a remote educational program, through videos or short messages, to encourage self-care
2) Case management system or software developed for the present study that will be used by the nurse manager to monitor vital data, weight and data on symptoms sent by the patient daily, through an al
3) Elective teleconsultations with a cardiologist to optimize clinical treatment or evaluate pre-established clinical alerts, as recommended by the guidelines, in week 1 and every 2 weeks, or dependin
4) Educational messages via app, twice a week, which will contain self-care strategies, guidance on the disease and reminders about scheduled medical appointments
5) Access to a channel for answering questions via “Whatsapp” on weekdays, managed by the nurse manager.
Sponsors
Faculdade de Medicina da Universidade Federal de Minas Gerais
Faculdade de Medicina da Universidade Federal de Minas Gerais
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Both sexes; age greater than 18 years; diagnosis of Heart Failure with left ventricular ejection fraction less than 50%, including assessment by Echocardiography, Cardiac Magnetic Resonance Imaging, or Myocardial Scintigraphy; hospitalization for Heart Failure with discharge anticipated within the next few days or recent hospitalization for Heart Failure with discharge within the past 2 weeks; at least one guideline-directed medical therapy medication (beta-blockers, ACE inhibitors/ARBs/ARNIs, or mineralocorticoid receptor antagonists) not initiated, or two of these medications prescribed at doses less than or equal to 50% of the target dose; and willingness to participate and provide written informed consent
Exclusion criteria
Exclusion criteria: Chronic Kidney Disease stage V; prior history of heart transplantation or currently active on the heart transplant waiting list; prior use of a ventricular assist device; Cardiac Amyloidosis; pregnancy or planning to become pregnant; estimated life expectancy of less than 6 months due to non-cardiac comorbidities, according to the investigator's judgment; receiving exclusive palliative care; current participation in another investigational drug or device study, or participation in another study within the previous 30 days; patient or caregiver living in the same household without access to a smartphone; patient without the cognitive capacity to make their own decisions; completely illiterate patients (unable to read and/or write) without a responsible caregiver; patient who, for any reason, will not be available to complete the study procedures (e.g., interviews) established in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect to observe a 1,0 point incremental increase in GDMT (guideline-directed medical therapy) score between hospital discharge (baseline) and after 3 months of follow-up in the intervention group compared to the control group. The GDMT score was developed by the “Heart Failure Academic Research Consortium Meeting” and described by Fiuzat et al in 2022 and it proposes that, in order to allow a comparison between GDMT quality between patients, a point scheme be used, anchored in the recommendations of the guidelines. In this proposal, points are distributed according to medication class and prescribed dose, creating a composite score that allows a more objective assessment of the treatment quality for each group. For this project, an adaptation of the score was performed, considering the treatment available through the Universal Health System in Brazil (Sistema Único de Saúde, SUS) at the present date and allowing a more granular assessment of the prescribed medication doses. The score can vary from 0 to 12 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect to observe a reduction in days lost due to all-cause hospitalizations or death during 3 months follow-up in the intervention group ;We expect to observe a reduction in days lost due to all-cause hospitalizations during 3 months follow-up in the intervention group ;We expect to observe a reduction in all-cause and cardiovascular deaths in the intervention group;We expect to observe a reduction in search for emergency care (ambulance or hospitals) in the intervention group;We expect to observe good Reach, Adoption, Effectiveness, Implementation and Maintenance (REAIM) of the intervention, based on the RE-AIM framework;We expect to observe an increase in the individual components of the GDMT (guideline-directed medical therapy) score by drug class;We expect to observe a reduction in all-cause hospitalizations;We expect to observe a reduction in heart failure hospitalizations (ICD-10 code I50);We expect to observe an incremental increase in the health status of participants, through the KCCQ-12 (Kansas City Cardiomyopathy Questionnaire), from the intervention group in relation to the control group;We expect to observe an incremental increase in the self-care behavior of participants, through the "European Self-Care Behavior Scale", from the intervention group in relation to the control group | — |
Countries
BR
Contacts
Public ContactLuisa Brant
Faculdade de Medicina da Universidade Federal de Minas Gerais
Outcome results
None listed