Brazilian Heart Insufficiency With Telemedicine

NCT04466852 | Recruiting DMC

• 1 other identifier: CAAE: 14894819.5.0000.5272
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 2

Brief 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

Heart Failure

Keywords

frail; public health; telemedicine

Outcome Measures

Primary Outcomes (1)

• composite of all-cause mortality or at least one hospital readmission

  Brasilian Heart Insufficiency with Telemedicine score based on changes in multiple parameters. For the subgroup of heart failure with reduced ejection fraction, best condition is 0 points and increasing points indicate worsening, worst 10 points and for the subgroup with preserved ejection fraction best is 0 points and worst is four points.

  six months after discharge

Secondary Outcomes (4)

• hospital-free days

  within 180 days post-discharge

• serious adverse events

  six months after discharge

• heart failure signs and symptoms frequency and intensity

  baseline and six months after discharge

• health-related quality of life

  baseline and six months after discharge

Other Outcomes (1)

• adherence to guidelines

  baseline and six months after discharge

Study Arms (2)

cardio-relay Family Clinic

ACTIVE COMPARATOR

Patients discharged from a Rio de Janeiro municipality hospital and identified as belonging to a Family Clinic randomized to cardio-share receive instruction for telemedicine consultations. These are based on their own devices, when available, or provided by their local community agents associated in the study.

Other: telemedicine-guided consultation

control Family Clinic

NO INTERVENTION

Patients discharged from a Rio de Janeiro municipality hospital and identified as belonging to a Family Clinic randomized to the control group or belonging who consent to participate in follow-up

Interventions

telemedicine-guided consultation OTHER

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.

cardio-relay Family Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Discharge from Hospital with one of the following ICD-10 diagnoses: (DI-11.0,-13.0, 42.0, 42.6, 42.9, 50.0, 50.1, 50.9) and follow-up from INC Hospital

You may not qualify if:

• Patients not willing to participate

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Instituto Nacional de Cardiologia de Laranjeiras: collaborator
• University of Copenhagen: collaborator
• Universidade Federal do Rio de Janeiro: collaborator

Study Sites (2)

Rio de Janeiro's Health Secretariat - Primary Care Practices

Rio de Janeiro, 20211-110, Brazil

RECRUITING

Instituto Nacional de Cardiologia Laranjeiras

Rio de Janeiro, 22240-006, Brazil

RECRUITING

Related Publications (21)

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Related Links

• projec description at University of Copenhagen

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Helena DOMINGUEZ, MD, PhD

  Frederiksberg hospital

  STUDY CHAIR

Central Study Contacts

Helena DOMINGUEZ, MD,PhD

CONTACT

+4522989343; maria.helena.dominguez.vall-lamora.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Initial feasibility phase with patients discharged from hospital to a pilot Primary Clinic, followed by cluster randomization at Primary Clinic level, stratified by type: i. Family Clinic (with certified Family doctors) or ii. Basic Unit (mix of non-certified doctors)

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: August 8, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Anticipated: 2 years after first inclusion - unlimited thereafter
• Access Criteria: All collected IPD, all IPD that underlie results in a publication

Locations

BR (2)