Brazilian Heart Insufficiency With Telemedicine

NCT04466852 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2024-12-09

No results posted yet for this study

Summary

A collaboration gap across sectors is a common problem in Denmark and Brazil. Brazilian Heart Insufficiency with Telemedicine (BRAHIT) will run in parallel with the ongoing Danish Reaching the Frail Elderly project (REAFEL - NCT04162548), supported by the Ministry of Higher Education and Health (Innovationsfonden - Grand Solutions), until 2021. REAFEL seeks a stronger collaboration between primary care and hospital cardiologists to manage frail elderly patients, using teleconsultation and data from mobile devices in Denmark.

Health resources are scarce in Brazil and a pressing need for the Municipal Secretary of Health of Rio de Janeiro is to reduce wait times to access some areas, as cardiology. When patients are stable after undergoing highly complex procedures in a tertiary hospital, are discharged to outpatient treatment at primary care but, a heterogenous expansion of the primary care system in the Rio de Janeiro municipality has created a great resistance from the population, and among cardiologists, to accept continuing cardiology treatment at the primary care system. Enhancing a collaboration between primary care and cardiologists, that is tangible for the patients, can relieve this pressure. The cross-sectorial collaboration in BRAHIT is based on the involvement of Instituto Nacional de Cardiologia (INC), a tertiary cardiology hospital, with primary investigator Aurora Issa (INC) and primary-and homecare in Rio de Janeiro, with primary investigator Leonardo Graever, Primary Care Special Advisor in the Municipality of Rio de Janeiro. The project proposal originates from Denmark and sponsors the project through a Danida grant (Window 2 from the Danish Foreign Ministry - Danida Fellowship Center 18-M03-KU) to the cardiologist Helena Domínguez, as associate professor in the Dept. of Biomedicine, UCPH, and consultant in Bispebjerg-Frederiksberg Hospital.

Being complex public health intervention studies, mixed methods are necessary to evaluate the value gained in the project and to provide research-based policy briefs. The methods include qualitative analyses and a cluster-randomization trial, the latter used for power calculation. Such calculation is based on adequate heart failure medications aggregated in a score constructed for this purpose. Secondary end-point is rate of number of readmissions for any cause, after discharge with heart failure diagnosis.

Conditions

Interventions

OTHER

telemedicine-guided consultation

Educational material is provided as short audiovisual films for understanding heart failure condition and management, how medicines work and their side effects, general advise on diets, exercise and importance of refraining from toxic exposure (smoke, alcohol, narcotics and damaging illegal medicines). Additionally, the patient (eventually assisted by their relatives and caregivers) can use this platform for learning basic important warning signs or cardiac decompensation based on feedback on recording regular measurements (weight, blood pressure and pulse and blood tests when needed) and symptoms. The cardiologist guides the patient and their Family/Basic doctors on the need for follow-up based on the parameters recorded. Videoconsultations with participation of the cardiologist, the Family/Basic doctor and the patient and relatives are used on demand.

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia de Laranjeiras

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • Universidade Federal do Rio de Janeiro

    collaborator OTHER
  • University Hospital Bispebjerg and Frederiksberg

    lead OTHER

Principal Investigators

  • Helena DOMINGUEZ, MD, PhD · Frederiksberg hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04466852 on ClinicalTrials.gov