Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring program with electronic alerts + Standard of care | Experimental |
| |
| Standard of care | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring with electronic alerts | Device | Patients assigned to this group will receive standard care plus a telemonitoring program. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| NT pro BNP | 90 days | |
| Medication adherence | 90 days | |
| Quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Cardiovascular de Buenos Aires | Recruiting | Buenos Aires | Buenos Aires F.D. | 1428 | Argentina |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of care | Other | Standard of care |
|
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 |