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Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Primary Purpose

Heart Failure, Acute Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Telemonitoring with electronic alerts
Standard of care
Sponsored by
Instituto Cardiovascular de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring telemonitoring, Heart Failure, Vulnerable phase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto Cardiovascular de Buenos AiresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Telemonitoring program with electronic alerts + Standard of care

Standard of care

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

NT pro BNP
Medication adherence
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.
First readmission for heart failure
Total number of readmissions for heart failure
Time to achieve the use of Guideline-Directed Medical Therapy
Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy

Full Information

First Posted
April 14, 2023
Last Updated
July 31, 2023
Sponsor
Instituto Cardiovascular de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT05972746
Brief Title
Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
October 7, 2023 (Anticipated)
Study Completion Date
November 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Cardiovascular de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acute Heart Failure
Keywords
telemonitoring, Heart Failure, Vulnerable phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring program with electronic alerts + Standard of care
Arm Type
Experimental
Arm Title
Standard of care
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Telemonitoring with electronic alerts
Intervention Description
Patients assigned to this group will receive standard care plus a telemonitoring program.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Self-care behavior
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
NT pro BNP
Time Frame
90 days
Title
Medication adherence
Time Frame
90 days
Title
Quality of life
Description
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.
Time Frame
90 days
Title
First readmission for heart failure
Time Frame
90 days
Title
Total number of readmissions for heart failure
Time Frame
90 days
Title
Time to achieve the use of Guideline-Directed Medical Therapy
Time Frame
90 days
Title
Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Instituto Cardiovascular de Buenos Aires
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucrecia Maria Burgos
Phone
541141057500
Email
lburgos@icba.com.ar
First Name & Middle Initial & Last Name & Degree
Lucrecia M Burgos, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

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