NCT02489565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2014

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

May 13, 2015

Last Update Submit

July 1, 2015

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseasestableTelemedicinePatient Discharge

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of participants with instability of the disease

    within one year after discharge

  • blood pressure control

    within one year after discharge

  • dyslipidemia control

    within one year after discharge

  • diabetes control

    within one year after discharge

Other Outcomes (3)

  • Number of participants with control of tobacco

    within one year after discharge

  • Number of participants in physical activity

    within one year after discharge

  • Access to primary health care

    within six months and one year after discharge

Study Arms (2)

Tertiary care

NO INTERVENTION

Outpatient from tertiary care with discharge criteria who remains in the tertiary care.

Primary care

EXPERIMENTAL

Outpatient discharge from tertiary care to a primary care near the patient's home with the support of telemedicine.

Other: Telemedicine

Interventions

TelemedicineOTHER

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.

Also known as: Primary care with the support of telemedicine
Primary care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32188310DERIVED

  • 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.

    PMID: 27387752DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

TelemedicinePrimary Health Care

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationComprehensive Health Care

Study Officials

  • Carisi A Polanczyk, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carisi A Polanczyk, PhD

CONTACT

+55 51 33596359carisi.anne@gmail.com

Joanna Lyra, PhD

CONTACT

+ 55 51 33596325joannalyra@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

July 3, 2015

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

November 1, 2017

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations

BR(1)