Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF

Conditions
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Heart Failure, Acute Heart Failure

Intervention / Treatment
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* Device: Telemonitoring with electronic alerts
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring program with electronic alerts + Standard of care<br> | Device: Telemonitoring with electronic alerts<br>* Patients assigned to this group will receive standard care plus a telemonitoring program.<br>Other: Standard of care<br>* Standard of care<br>|
| Placebo Comparator: Standard of care<br> | Other: Standard of care<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT pro BNP |  | 90 days | 
| Medication adherence |  | 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. | 90 days | 
| First readmission for heart failure |  | 90 days | 
| Total number of readmissions for heart failure |  | 90 days | 
| Time to achieve the use of Guideline-Directed Medical Therapy |  | 90 days | 
| Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemonitoring, Heart Failure, Vulnerable phase