Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial
EVIT-HF
1 other identifier
interventional
368
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 12, 2024
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
March 16, 2026
March 1, 2026
2 years
December 9, 2024
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure
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)
365 days after discharge
Other Outcomes (5)
Hospitalization Rates for Heart Failure within 365 Days Post-Discharge
365 days after discharge
Heart Failure Knowledge Assessed by the HF Knowledge Questionnaire
365 days after discharge
Adherence to Heart Failure Treatment Regimens asseded by "Adherence to HF treatment instrument"
365 days after discharge
- +2 more other outcomes
Study Arms (2)
Videomonitoring Group
EXPERIMENTALVideomonitoring by cardiovascular nursing
Voice call group
NO INTERVENTIONVoice call by cardiovascular nurses
Interventions
Videomonitoring provide by cardiovascular nurses using motivational interview and teach-back
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federal University of Uberlandialead
- Federal University of Rio Grande do Sulcollaborator
- Universidade Federal do Triangulo Mineirocollaborator
Study Sites (1)
Federal University of Uberlândia
Uberlândia, Minas Gerais, 38405354, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
OMAR DE ALMEIDA NETO, PhD
Federal University of Uberlandia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head
Study Record Dates
First Submitted
December 9, 2024
First Posted
December 12, 2024
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
After careful consideration, we have decided not to share the individual patient data (IPD) from this study. This decision was made based on privacy concerns, participant confidentiality, and the specifics of the informed consent, which does not explicitly include authorization for sharing individual data. Furthermore, the study involves sensitive data that could compromise participants' privacy, even with anonymization and de-identification processes. Ensuring the safety and well-being of participants remains our top priority, and therefore, we have opted not to make individual data available on public platforms or repositories. The aggregated results and conclusions of the study will be shared through scientific publications, conferences, and other appropriate platforms to ensure that the findings benefit the scientific community and society at large.