Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Instituto Cardiovascular de Buenos Aires
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Self-care behavior
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Lucrecia Maria Burgos
Unit coordinator
Instituto Cardiovascular de Buenos Aires
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Self-care behavior
Time Frame: 90 days
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)
Secondary Outcomes
- Quality of life(90 days)
- Medication adherence(90 days)
- Time to achieve the use of Guideline-Directed Medical Therapy(90 days)
- First readmission for heart failure(90 days)
- NT pro BNP(90 days)
- Total number of readmissions for heart failure(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)