Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Acute Heart Failure
• Intervention / Treatment: Other: Standard of care; Device: Telemonitoring with electronic alerts

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1428
      • Recruiting
      • Instituto Cardiovascular de Buenos Aires
      • Contact: Lucrecia Maria Burgos; Phone Number: 541141057500; Email: lburgos@icba.com.ar
      • Principal Investigator: Lucrecia M Burgos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemonitoring program with electronic alerts + Standard of care	Other: Standard of care; Standard of care; Device: Telemonitoring with electronic alerts; Patients assigned to this group will receive standard care plus a telemonitoring program.
Placebo Comparator: Standard of care	Other: Standard of care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NT pro BNP		90 days
Medication adherence		90 days
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
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

Collaborators and Investigators

• Sponsor: Instituto Cardiovascular de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): October 7, 2023
• Study Completion (Estimated): November 7, 2023

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; telemonitoring; Vulnerable phase
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Institute of Psychiatry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No