Clinical trial NCT02489565: Telemedicine Qualifying Transition Between Tertiary and Primary Health Care in Stable Coronary Artery Disease Patients
Official title: Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
stable
Telemedicine
Patient Discharge
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Ministry of Health, Brazil
name: Federal University of Rio Grande do Sul
First posted: 2015-07-03
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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

Primary outcomes:
measure: Number of participants that stay in Canadian Cardiovascular Society (CCS) Functional Classification of Angina I and II as a measure of safety
timeFrame: within one year after discharge
Secondary outcomes:
measure: Number of participants with instability of the disease
timeFrame: within one year after discharge
measure: blood pressure control
timeFrame: within one year after discharge
measure: dyslipidemia control
timeFrame: within one year after discharge
measure: diabetes control
timeFrame: within one year after discharge
Other outcomes:
measure: Number of participants with control of tobacco
timeFrame: within one year after discharge
measure: Number of participants in physical activity
timeFrame: within one year after discharge
measure: Access to primary health care
timeFrame: within six months and one year after discharge
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health)
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Carisi A Polanczyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.