Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure; Acute Heart Failure
• Interventions: Other: Standard of care; Device: Telemonitoring with electronic alerts

• Registration Number: NCT05972746
• Lead Sponsor: Instituto Cardiovascular de Buenos Aires

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Study First Submitted: 2023-04-14
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2023-10-07
• Study Completion: 2023-11-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	-
Telemonitoring program with electronic alerts + Standard of care	Standard of care	-
Telemonitoring program with electronic alerts + Standard of care	Telemonitoring with electronic alerts	-

Primary Outcome Measures

Name	Time	Method
Self-care behavior	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 Outcome Measures

Name	Time	Method
First readmission for heart failure	90 days
Quality of life	90 days	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.
Medication adherence	90 days
Time to achieve the use of Guideline-Directed Medical Therapy	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

Trial Locations

Locations (1)

Instituto Cardiovascular de Buenos Aires; 🇦🇷 Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina