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

NCT ID: NCT06731166

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-06-01

Brief Summary

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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

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Conditions

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Heart Failure With Reduced Ejection Fraction (HFrEF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Videomonitoring Group

Videomonitoring by cardiovascular nursing

Group Type EXPERIMENTAL

self-care

Intervention Type BEHAVIORAL

Videomonitoring provide by cardiovascular nurses

Voice call group

Voice call by cardiovascular nurses

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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self-care

Videomonitoring provide by cardiovascular nurses

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Universidade Federal do Triangulo Mineiro

OTHER

Sponsor Role collaborator

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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OMAR PEREIRA DE ALMEIDA NETO

Head

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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OMAR DE ALMEIDA NETO, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Central Contacts

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Omar Pereira de Almeida Neto, PhD

Role: CONTACT

+5534992132987

Patricia magnabosco, PhD

Role: CONTACT

+5534914871477

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ethics committee 5.568.868

Identifier Type: -

Identifier Source: org_study_id

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