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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

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date July 3, 2015
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2015)
  • 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
  • Number of participants in physical activity [ Time Frame: within one year after discharge ]
    maintenance or start regular physical activity post intervention
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Telemedicine Qualifying Transition Between Tertiary and Primary Health Care in Stable Coronary Artery Disease Patients
Official Title  ICMJE Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Telemedicine
Publications * Batista Jd, Furtado MV, Katz N, Agostinho MR, Neto BS, Harzheim E, Polanczyk CA. Telemedicine-supported transition of stable coronary artery disease patients from tertiary to primary health care facilities: protocol for a randomized non-inferiority trial. BMC Health Serv Res. 2016 Jul 7;16:227. doi: 10.1186/s12913-016-1469-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2015)
264
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489565
Other Study ID Numbers  ICMJE GPPG 14-0206
401463/2013-3 ( Other Grant/Funding Number: MCTI/CNPq/Ministry of Health - SCTIE/DECIT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Ministry of Health, Brazil
  • Federal University of Rio Grande do Sul
Investigators  ICMJE
Principal Investigator: Carisi A Polanczyk, PhD Hospital de Clínicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP