Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

NCT05972746 | Unknown DMC

• 1 other identifier: 0
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Acute Heart Failure

Keywords

telemonitoring; Heart Failure; Vulnerable phase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• NT pro BNP

  90 days

• Medication adherence

  90 days

• Quality of life

  90 days

• First readmission for heart failure

  90 days

• Total number of readmissions for heart failure

  90 days

Study Arms (2)

Telemonitoring program with electronic alerts + Standard of care

EXPERIMENTAL

Device: Telemonitoring with electronic alerts; Other: Standard of care

Standard of care

PLACEBO COMPARATOR

Other: Standard of care

Interventions

Telemonitoring with electronic alerts DEVICE

Patients assigned to this group will receive standard care plus a telemonitoring program.

Telemonitoring program with electronic alerts + Standard of care

Standard of care OTHER

Standard of care

Standard of care; Telemonitoring program with electronic alerts + Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Cardiovascular de Buenos Aires: lead

Study Sites (1)

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1428, Argentina

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unit coordinator

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: August 2, 2023
• Study Start: October 7, 2022
• Primary Completion: October 7, 2023
• Study Completion: November 7, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

AR (1)