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

Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Telemedicine

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: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health)
      • Contact: Carisi A Polanczyk, PhD; Phone Number: +555133596359; Email: carisi.anne@gmail.com
      • Contact: Joanna L Batista, PhD; Phone Number: +555133596325; Email: joannalyra@gmail.com
      • Sub-Investigator: Mariana V Furtado, PhD
      • Sub-Investigator: Natan Katz, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Primary care with the support of telemedicine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with instability of the disease	the need to seek emergency care for cardiovascular disease post intervention.	within one year after discharge
blood pressure control	verified to maintain systemic blood pressure from the observation of a variation of at least 5% in pre and post intervention measurements	within one year after discharge
dyslipidemia control	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	within one year after discharge
diabetes control	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	within one year after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with control of tobacco	remain without smoking for non smokers; and smoking cessation for smokers	within one year after discharge
Number of participants in physical activity	maintenance or start regular physical activity post intervention	within one year after discharge
Access to primary health care	medical consultation in Basic Health Unit held with assessment of current medications and providing prescription.	within six months and one year after discharge

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul; Ministry of Health, Brazil; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Carisi A Polanczyk, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

General Publications

• Ruschel KB, Rados DR, Furtado MV, Batista JDL, Katz N, Harzheim E, Polanczyk CA. Transition of care of stable ischaemic heart disease patients from tertiary to primary care with telemedicine support: Randomized noninferiority clinical trial. J Telemed Telecare. 2022 Jan;28(1):52-57. doi: 10.1177/1357633X20906648. Epub 2020 Mar 18.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Telemedicine; Coronary Artery Disease; Patient Discharge; stable
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: GPPG 14-0206; 401463/2013-3 (Other Grant/Funding Number: MCTI/CNPq/Ministry of Health - SCTIE/DECIT)