Coronary Artery DiseaseTele_DACNCT02489565
Telemedicine Qualifying Transition Between Tertiary and Primary Health Care in Stable Coronary Artery Disease Patients
A study testing Telemedicine in people with Coronary Artery Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Avaliação de Tecnologia em Saúde (Institute of Technology Assessment in Health)
Porto Alegre, Rio Grande do Sul, 90035-903
Carisi A Polanczyk, PhD, +555133596359, carisi.anne@gmail.com
Joanna L Batista, PhD, +555133596325, joannalyra@gmail.com
About this study
Official title: Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial
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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- Telemedicine
- Keywords
- Coronary Artery Disease, stable, Telemedicine, Patient Discharge
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Also called Primary care with the support of 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within one year after discharge
Secondary outcomes (4)
Number of participants with instability of the disease
the need to seek emergency care for cardiovascular disease post intervention.
Measured: 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
Measured: 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
Measured: 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
Measured: within one year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil, Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Carisi A Polanczyk, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489565
- Sponsor's protocol ID
- GPPG 14-0206
- Other IDs
- 401463/2013-3
- Acronym
- Tele_DAC
- Status last verified
- Jul 2015
- First submitted
- 13 May 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32188310Batista 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.
PubMed 27387752
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02489565
- Acronym / sponsor ID
- Tele_DAC / GPPG 14-0206
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, stable, Telemedicine, Patient Discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil, Federal University of Rio Grande do Sul
- Study start
- May 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tertiary care | No intervention | –Outpatient from tertiary care with discharge criteria who remains in the tertiary care. |
| Primary care | Experimental | Other: TelemedicineOutpatient discharge from tertiary care to a primary care near the patient's home with the support of telemedicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineAlso: Primary care with the support of telemedicineOutpatient 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. | Other | Primary care |
Primary outcome
Number of participants that stay in Canadian Cardiovascular Society (CCS) Functional Classification of Angina I and II as a measure of safety
Time frame: within one year after discharge
Not evolve into a higher class than the measure before the intervention
4 secondary outcomes
Number of participants with instability of the disease
Time frame: within one year after discharge
blood pressure control
Time frame: within one year after discharge
dyslipidemia control
Time frame: within one year after discharge
diabetes control
Time frame: within one year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Derived from this study: PubMed 32188310Ruschel 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.
- Derived from this study: PubMed 27387752Batista 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carisi A Polanczyk, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Coronary Artery Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carisi A Polanczyk, PhD (+55 51 33596359, carisi.anne@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that stay in Canadian Cardiovascular Society (CCS) Functional Classification of Angina I and II as a measure of safety (time frame: within one year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.