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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05972746
Other study ID # 0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 7, 2022
Est. completion date November 7, 2023

Study information

Verified date July 2023
Source Instituto Cardiovascular de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date November 7, 2023
Est. primary completion date October 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Telemonitoring with electronic alerts
Patients assigned to this group will receive standard care plus a telemonitoring program.
Other:
Standard of care
Standard of care

Locations

Country Name City State
Argentina Instituto Cardiovascular de Buenos Aires Buenos Aires Ciudad Autónoma De Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Instituto Cardiovascular de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

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