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Telemedicine Qualifying Transition Between Tertiary and Primary Health Care in Stable Coronary Artery Disease Patients (Tele_DAC)

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ClinicalTrials.gov Identifier: NCT02489565
Recruitment Status : Unknown
Verified July 2015 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Health, Brazil
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
The purpose of this study is to determine whether the telemedicine use in primary health care is effective in the accompaniment of stable coronary artery disease patients who were discharged from the tertiary health care clinics.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Telemedicine Not Applicable

Detailed Description:
This study is a randomized non-inferiority trial for patients with chronic coronary artery disease from a tertiary hospital with outpatient discharge criteria. The purpose is to compare the use of telemedicine in the quality of care transition between tertiary care and primary care patients (intervention group), with patients who remain in the outpatient clinic of a tertiary hospital (control group).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial
Study Start Date : May 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Tertiary care
Outpatient from tertiary care with discharge criteria who remains in the tertiary care.
Experimental: Primary care
Outpatient discharge from tertiary care to a primary care near the patient's home with the support of telemedicine.
Other: Telemedicine
Outpatient discharge from tertiary care to primary care with a letter of referral explaining about the study containing phone number from telemedicine and a letter with the patient's history in the hospital. Two months after discharge, the telemedicine's cardiologist initiates contact with the primary care's physician about patient follow-up.
Other Name: Primary care with the support of telemedicine




Primary Outcome Measures :
  1. Number of participants that stay in Canadian Cardiovascular Society (CCS) Functional Classification of Angina I and II as a measure of safety [ Time Frame: within one year after discharge ]
    Not evolve into a higher class than the measure before the intervention


Secondary Outcome Measures :
  1. Number of participants with instability of the disease [ Time Frame: within one year after discharge ]
    the need to seek emergency care for cardiovascular disease post intervention.

  2. blood pressure control [ Time Frame: within one year after discharge ]
    verified to maintain systemic blood pressure from the observation of a variation of at least 5% in pre and post intervention measurements

  3. dyslipidemia control [ Time Frame: within one year after discharge ]
    verified to maintain dyslipidemia control through laboratory examination, from the observation of a variation of at least 5% in pre and post intervention measurements of Low Density Lipoproteins (LDL) in blood

  4. diabetes control [ Time Frame: within one year after discharge ]
    verified to maintain diabetes control through laboratory examination, from the observation of a variation of at least 5% in pre and post intervention measurements of fasting glucose in the blood


Other Outcome Measures:
  1. Number of participants with control of tobacco [ Time Frame: within one year after discharge ]
    remain without smoking for non smokers; and smoking cessation for smokers

  2. Number of participants in physical activity [ Time Frame: within one year after discharge ]
    maintenance or start regular physical activity post intervention

  3. Access to primary health care [ Time Frame: within six months and one year after discharge ]
    medical consultation in Basic Health Unit held with assessment of current medications and providing prescription.



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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:

  • individuals with diagnosis of Coronary Artery Disease (CAD) in Canadian Cardiovascular Society (CCS)'s functional classification of angina Class I or II
  • patients who did not submit hospitalization for cardiovascular disease in the last year

Exclusion Criteria:

  • patients who were not followed up in the health service to at least one year
  • unstable patients requiring adjustments of medications or who are performing some diagnostic evaluation at discharge outpatient

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): NCT02489565


Contacts
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Contact: Carisi A Polanczyk, PhD +55 51 33596359 carisi.anne@gmail.com
Contact: Joanna Lyra, PhD + 55 51 33596325 joannalyra@gmail.com

Locations
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Brazil
Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Carisi A Polanczyk, PhD    +555133596359    carisi.anne@gmail.com   
Contact: Joanna L Batista, PhD    +555133596325    joannalyra@gmail.com   
Sub-Investigator: Mariana V Furtado, PhD         
Sub-Investigator: Natan Katz, MsC         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Health, Brazil
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Carisi A Polanczyk, PhD Hospital de Clínicas de Porto Alegre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02489565     History of Changes
Other Study ID Numbers: GPPG 14-0206
401463/2013-3 ( Other Grant/Funding Number: MCTI/CNPq/Ministry of Health - SCTIE/DECIT )
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by Hospital de Clinicas de Porto Alegre:
Coronary Artery Disease
stable
Telemedicine
Patient Discharge

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases