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

Coronary Artery Disease Clinical Trial

— Tele_DAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489565
• Other study ID #: GPPG 14-0206
• Secondary ID: 401463/2013-3
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2015
• Last updated: July 1, 2015
• Start date: May 2014
• Est. completion date: November 2017

Study information

• Verified date: July 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Carisi A Polanczyk, PhD
• Phone: +55 51 33596359
• Email: carisi.anne[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health)	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Rio Grande do Sul, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with control of tobacco	remain without smoking for non smokers; and smoking cessation for smokers	within one year after discharge	Yes
Other	Number of participants in physical activity	maintenance or start regular physical activity post intervention	within one year after discharge	Yes
Other	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	Yes
Primary	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	Yes
Secondary	Number of participants with instability of the disease	the need to seek emergency care for cardiovascular disease post intervention.	within one year after discharge	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes