Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF)

• Registration Number: NCT06731166
• Lead Sponsor: Federal University of Uberlandia

Brief Summary

The goal of this clinical trial is to measure the effectiveness of video monitoring associated with the transition of care for patients with heart failure.

The main questions it aims to answer is: Is video monitoring superior to monitoring via audio calls in patients with heart failure?

Researchers will compare monitoring by video to a monitoring by audio to see if drug videomonitoring works to improve selfcare in heart failure and other outocomes.

Participants will:

intervention group receive video calls guided by cardiologist nurses at 7, 30, 60, 180 and 365 days after hospital discharge.

the control group will receive audio calls for data collection, at the same time mentioned.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-20
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients aged 18 years or older;
• Admitted for decompensated HFrEF
• Ejection fraction less than 40% confirmed by echocardiogram performed in the last 3 months
• Who access to a mobile device with internet access

Exclusion Criteria

• heart transplant waiting list;
• who had undergone coronary artery bypass in the last 3 months ;
• who were in palliative care;
• who had a life expectancy of less than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure	365 days after discharge	European Self-Care Scale The European self-care scale consists of 12 questions with a single domain related to self-care behavior. Responses to each item range from 1, "I completely agree", to 5, "I completely disagree", following a five-point Likert scale. The total score is obtained by summing all the responses, which can range from 12 to 60. Low values indicate better self-care. The items concern the various self-care behaviors of patients with heart failure, such as checking daily weight (item 1), rest (items 2 and 7), seeking help from the healthcare team (items 3, 4, 5 and 8), fluid restriction (item 6), diet (item 9), medication adherence (item 10), flu vaccination (item 11) and exercise (item 12)

Secondary Outcome Measures

Name	Time	Method
Rate of Cardiovascular Mortality within 365 Days Post-Discharge	365 days after discharge	Number of patients with heart failure who died during the trial