Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972746
• Other study ID #: 0
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

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