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Brazilian Heart Insufficiency With Telemedicine (BRAHIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466852
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Instituto Nacional de Cardiologia de Laranjeiras
Information provided by (Responsible Party):
Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg

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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: telemedicine-guided consultation Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Initial feasibility phase with patients discharged from INC hospital to one pilot Primary Clinic, followed by cluster randomization at Primary Clinic level, stratified by Family Clinic (with certified Family doctors) or Basic Unit (mix of non-certified doctors)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Otimização do Sistema de Saúde no Brasil Com Telemedicina
Estimated Study Start Date : July 20, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: cardio-relay Family Clinic
Patients discharged from INC hospital and identified as belonging to a Family Clinic randomized to cardio-relay 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
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.

No Intervention: control Family Clinic
Patients discharged from INC hospital and identified as belonging to a Family Clinic randomized to the control group or belonging who consent to participate in follow-up
Active Comparator: cardio-relay Basic Clinic
Patients discharged from INC hospital and identified as belonging to a Basic Clinic randomized to cardio-relay 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
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.

No Intervention: control Basic Clinic
Patients discharged from INC hospital and identified as belonging to a Basic Clinic randomized to the control group or belonging who consent to participate in follow-up



Primary Outcome Measures :
  1. Adequate use of heart failure medicines [ Time Frame: quarterly until one year after discharge ]
    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.


Secondary Outcome Measures :
  1. Readmissions [ Time Frame: one year after discharge ]
    Number of eadmissions for any cause

  2. Patient reported outcomes [ Time Frame: 3 months and 12 months after discharge ]
    Based on open-question interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Discharge from INC 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)

Exclusion Criteria:

  • Terminal condition (end-of-life expected within less than 12 months)
  • Patientens not willing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466852


Contacts
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Contact: Helena DOMINGUEZ, MD,PhD +4522989343 maria.helena.dominguez.vall-lamora.02@regionh.dk

Locations
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Brazil
Instituto Nacional de Cardiologia Laranjeiras
Rio De Janeiro, Brazil, 22240-006
Contact: Aurora FC Issa, MD, PhD    +55 21 2285-3344    aurora.felice@inc.saude.gov.br   
Contact: Leonardo Graever       sap.smsrj@gmail.com   
Principal Investigator: Aurora FC Issa, MD, PhD         
Sub-Investigator: Leonardo Graever, MD, Prof.         
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
Instituto Nacional de Cardiologia de Laranjeiras
Investigators
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Study Chair: Helena DOMINGUEZ, MD, PhD Frederiksberg hospital
Publications:

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Responsible Party: Helena DOMINGUEZ, MD, PhD, Associate Professor, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT04466852    
Other Study ID Numbers: CAAE: 14894819.5.0000.5272
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No IPD but data
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Anticipated: 2 years after first inclusion - unlimited thereafter
Access Criteria: All collected IPD, all IPD that underlie results in a publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg:
frail
public health
telemedicine
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases