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

Study Overview
=================
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).

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Telemedicine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Tertiary care<br>Outpatient from tertiary care with discharge criteria who remains in the tertiary care. | |
| Experimental: Primary care<br>Outpatient discharge from tertiary care to a primary care near the patient's home with the support of telemedicine. | Other: Telemedicine<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Telemedicine, Patient Discharge, stable