Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Sponsor

Instituto Cardiovascular de Buenos Aires (Other)

Overall Status

Recruiting

CT.gov ID

NCT05972746

Collaborator

(none)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Acute Heart Failure	Device: Telemonitoring with electronic alerts Other: Standard of care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 7, 2022

Anticipated Primary Completion Date :

Oct 7, 2023

Anticipated Study Completion Date :

Nov 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemonitoring program with electronic alerts + Standard of care	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
Placebo Comparator: Standard of care	Other: Standard of care Standard of care

Arm

Intervention/Treatment

Experimental: Telemonitoring program with electronic alerts + Standard of care

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

Placebo Comparator: Standard of care

Other: Standard of care

Standard of care

Outcome Measures

Primary Outcome Measures

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

NT pro BNP [90 days]
Medication adherence [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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Cardiovascular de Buenos Aires	Buenos Aires	Ciudad Autónoma De Buenos Aires	Argentina	1428

Sponsors and Collaborators

Instituto Cardiovascular de Buenos Aires

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lucrecia Maria Burgos, Unit coordinator, Instituto Cardiovascular de Buenos Aires

ClinicalTrials.gov Identifier:

NCT05972746

Other Study ID Numbers:

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lucrecia Maria Burgos, Unit coordinator, Instituto Cardiovascular de Buenos Aires

telemonitoring

Heart Failure

Vulnerable phase

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Aug 2, 2023