Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Instituto Cardiovascular de Buenos Aires110 enrolled

Overview

This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. And secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Heart Failure Acute Heart Failure

Interventions

Telemonitoring with electronic alertsDEVICE

Patients assigned to this group will receive standard care plus a telemonitoring program.

Standard of careOTHER

Standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute HF within 10 days prior to randomization. * Own a smartphone (Smartphone) with internet Ability to speak and read Spanish. * Residence in the metropolitan area of Buenos Aires Exclusion Criteria: * Pregnancy * Alcohol or drug abuse * Kidney failure in hemodialysis, * Inability to use the app (Ex: cognitive impairment, lack of social support, lack of ability to communicate) * Active cancer * Life expectancy less than 1 year * Candidates for care home or institutional end of life * Severe psychiatric illness * Planned cardiac surgery * Patient unable or unwilling to give informed consent to participate.

Locations (1)

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

RECRUITING

Outcomes

Primary Outcomes

Self-care behavior

The EHFScBS scale will be used. It consists of a self-administered questionnaire with 12 items addressing various aspects of patient self-care. Each item is scored from 1 (completely agree/always) to 5 (completely disagree/never). The overall score can range from 12 (best self-care) to 60 (worst self-care)

Time frame: 90 days

Secondary Outcomes

NT pro BNP

Time frame: 90 days

Medication adherence

Time frame: 90 days

Quality of life

The specific Quality of Life (QoL) related to heart failure will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), which consists of 21 items. Participants rate their perceptions of how heart failure and its treatment affect their daily life on a 6-point Likert scale ranging from 0 (no impairment) to 5 (very impaired). Therefore, lower scores indicate better specific QoL related to heart failure, and a change of 5 points is considered the minimum clinically significant change \[30\]. The MLHFQ yields a total QoL score and separate scores for the physical and emotional well-being sub-scales.

Time frame: 90 days

First readmission for heart failure

Time frame: 90 days

Total number of readmissions for heart failure

Time frame: 90 days

Time to achieve the use of Guideline-Directed Medical Therapy

Time frame: 90 days

Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.