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Completed

NCT Number: NCT06731166

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Uberlândia

Uberlândia, Minas Gerais, 38405354, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-care

Behavioral

Videomonitoring provide by cardiovascular nurses using motivational interview and teach-back

Primary outcomes

  1. 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)

Secondary outcomes

  1. Frailty

    Time frame: 365 days after discharge

    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.

  2. Death Rates for Heart Failure within 365 Days Post-Discharge

    Time frame: 365 days after discharge

    Number of death of patients with heart failure during the trial

  3. Cardiorespiratory Fitness Assessed by the Veterans Specific Activity Questionnaire (VSAQ)

    Time frame: 365 days after discharge

    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

  4. Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: 365 days after discharge

    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

  5. Adherence to Heart Failure Treatment Regimens asseded by "Adherence to HF treatment instrument"

    Time frame: 365 days after discharge

    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

  6. Heart Failure Knowledge Assessed by the HF Knowledge Questionnaire

    Time frame: 365 days after discharge

    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

  7. Hospitalization Rates for Heart Failure within 365 Days Post-Discharge

    Time frame: 365 days after discharge

    Number of hospitalization of patients with heart failure during the trial

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Collaborators

  • Federal University of Rio Grande do Sul
  • Universidade Federal do Triangulo Mineiro

Registry information

Acronym: EVIT-HF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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