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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Other: Telemedicine

• Registration Number: NCT02489565
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-05-13
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-01
• Last Update Submitted: 2015-07-01
• Study First Posted: 2015-07-03
• Last Update Posted: 2015-07-03
• Primary Completion: 2017-05
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary care	Telemedicine	Outpatient discharge from tertiary care to a primary care near the patient's home with the support of telemedicine.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
diabetes control	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
Number of participants with instability of the disease	within one year after discharge	the need to seek emergency care for cardiovascular disease post intervention.
blood pressure control	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	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

Trial Locations

Locations (1)

Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health); 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil