Heart Failure With Reduced Ejection Fraction (HFrEF)EVIT-HFNCT06731166
Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial
A study testing self-care in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Federal University of Uberlandia at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlândia
Uberlândia, Minas Gerais, 38405354
About this study
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.
- Being tested
- self-care
- Keywords
- Heart Failure, Nursing Care, Clinical Trial, Telenursing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-careBehavioural
Videomonitoring provide by cardiovascular nurses using motivational interview and teach-back
| Study group | Role | What they receive |
|---|---|---|
| Videomonitoring Group | Experimental | Videomonitoring by cardiovascular nursing Receives: Behavioral: self-care |
| Voice call group | No intervention | Voice call by cardiovascular nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 365 days after discharge
Secondary outcomes (7)
Frailty
Tilburg Frailty Indicator The Tilburg Frailty Indicator (TFI) is a self-report questionnaire that assesses frailty across three domains: physical (8 items), psychological (4 items), and social (3 items). Total scores range from 0 to 15, with higher scores indicating greater frailty. A total score of ≥ 5 is used to classify individuals as frail.
Measured: 365 days after discharge
Death Rates for Heart Failure within 365 Days Post-Discharge
Number of death of patients with heart failure during the trial
Measured: 365 days after discharge
Cardiorespiratory Fitness Assessed by the Veterans Specific Activity Questionnaire (VSAQ)
Cardiorespiratory fitness Cardiorespiratory fitness will be assessed by the Veterans Specific Activity Questionnaire (VSAQ), a brief questionnaire that consists of a list of activities presented in a progressive order according to metabolic equivalents (METs). Participants are instructed to determine which activities would cause fatigue, shortness of breath, chest discomfort, or necessity of stopping due to exhaustion if performed for a few minutes. The VSAQ was scored as a whole number (1 to 13 METs) directly from the subject's response. The VSAQ score will be adjusted by age and METs following a regression equation to predict aerobic fitness: METs = 4.7 + 0.97 × VSAQ - 0.06 × age
Measured: 365 days after discharge
Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Quality of life in HF patients The quality of life of patients with HF will be assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), a disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales representing different degrees of impact of HF on quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst quality of life), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (a total of 21) are considered only for the calculation of the total score
Measured: 365 days after discharge
Adherence to Heart Failure Treatment Regimens asseded by "Adherence to HF treatment instrument"
Adherence to HF treatment Adherence to HF treatment will be assessed by an instrument with 10 questions related to the use of prescribed medications, daily weight checks, salt intake, water intake and attendance at scheduled appointments and exams. Each question has 3 to 4 alternatives; for questions with 4 alternatives, the score varied from 0 to 4 points, and for questions with 3 alternatives, the score varied from 0 to 3 points. Therefore, the general adherence score could vary from 0 to 26 points. A minimum score of 18 points will be considered a cutoff point for patients adhering to treatment, corresponding to 70% adherence
Measured: 365 days after discharge
Heart Failure Knowledge Assessed by the HF Knowledge Questionnaire
HF Knowledge Questionnaire The HF knowledge questionnaire consists of 14 questions related to domains such as knowledge of the appropriate diet in HF, knowledge about the amount of fluids ingested and weight control, knowledge about pharmacological and nonpharmacological treatment of HF and general knowledge about the disease. The knowledge score is determined by the sum of the number of correct answers: for the correct question, the patient gains one point, and for each incorrect answer, the patient loses one point. In this way, the score ranges from 0 to 14
Measured: 365 days after discharge
Hospitalization Rates for Heart Failure within 365 Days Post-Discharge
Number of hospitalization of patients with heart failure during the trial
Measured: 365 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Universidade Federal do Triangulo Mineiro
- Responsible party
- Principal investigator, OMAR PEREIRA DE ALMEIDA NETO, Federal University of Uberlandia
- Investigators
- OMAR DE ALMEIDA NETO, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731166
- Sponsor's protocol ID
- ethics committee 5.568.868
- Acronym
- EVIT-HF
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06731166
- Acronym / sponsor ID
- EVIT-HF / ethics committee 5.568.868
- Keywords
- Heart Failure, Nursing Care, Clinical Trial, Telenursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Universidade Federal do Triangulo Mineiro
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videomonitoring Group | Experimental | Behavioral: self-careVideomonitoring by cardiovascular nursing |
| Voice call group | No intervention | –Voice call by cardiovascular nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-careVideomonitoring provide by cardiovascular nurses using motivational interview and teach-back | Behavioural | Videomonitoring Group |
Primary outcome
Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure
Time frame: 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)
7 secondary outcomes
Frailty
Time frame: 365 days after discharge
Death Rates for Heart Failure within 365 Days Post-Discharge
Time frame: 365 days after discharge
Cardiorespiratory Fitness Assessed by the Veterans Specific Activity Questionnaire (VSAQ)
Time frame: 365 days after discharge
Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 365 days after discharge
Adherence to Heart Failure Treatment Regimens asseded by "Adherence to HF treatment instrument"
Time frame: 365 days after discharge
Heart Failure Knowledge Assessed by the HF Knowledge Questionnaire
Time frame: 365 days after discharge
Hospitalization Rates for Heart Failure within 365 Days Post-Discharge
Time frame: 365 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OMAR DE ALMEIDA NETO, PhD principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-care in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure (time frame: 365 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.