Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome (TELECOR)

February 20, 2025 updated by: Germans Trias i Pujol Hospital

Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome: Randomized Clinical Trial TELECOR Study

The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors via the following variables: % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits; Adherence to cardiac rehabilitation program; Adherence to pharmacological treatment; Quality of Life improvement ; Anxiety and depression; Satisfaction rate; Functional capacity; Cardiac cause hospitalization; Emergency visits; and Angioplasty revascularization procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Germans Trias i Pujol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute myocardial infarct prior to 2 months
  • Killip I-II classification
  • No previous myocardial infarction
  • No angina pectoris
  • No ischemia in complementary explorations
  • Normal arterial pressure response during stress test.
  • No relevant arrythmias
  • Left ventricular ejection fraction >= 35%
  • Functional capacity >5 METS
  • Signing of the inform consent

Exclusion Criteria:

  • Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program
  • Impossibility for digital media use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tele-rehabilitation
Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient is guided via a face-to-face telematic call to perform the cardiac rehabilitation exercises and life style education.
Behavioral: Experimental: Cardiac tele-rehabilitation
Patients will connect to their health care provider via a tele-call
Active Comparator: In person cardiac rehabilitation
Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient attends an in-person cardiac rehabilitation exercises and life style education at the hospital.
Behavioral: Other: Control, in person cardiac rehabilitation
Patients will attend an ambulatory cardiac rehabilitation unit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
% patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits
Time Frame: • (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]

Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits

  1. Blood pressure <140/90 mmHg
  2. Maintaining normal weight or a 5% reduction in body weight if BMI > 25 kg/m2
  3. Abdominal circumference <88 cm in women and <102 cm in men
  4. LDL <50 mg/dl and a reduction of >50% in initial LDL levels
  5. Smoking cessation
  6. Adherence to a heart-healthy diet (PREDIMED Questionnaire* ≥7)
  7. Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ** result (International Physical Activity Questionnaire)
• (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to cardiac rehabilitation program
Time Frame: 2 months +-30 day
% of patients adherent to cardiac rehabilitation program
2 months +-30 day
Functional capacity
Time Frame: 0-2months +- 30 days
Functional capacity by cardiac stress test (METS)
0-2months +- 30 days
Cardiac cause hospitalization
Time Frame: 6 months +-7days
Cardiac cause hospitalization
6 months +-7days
Emergency visits
Time Frame: 6 months +-7days
Emergency visits
6 months +-7days
Adherence to pharmacological treatment
Time Frame: 0-2months +- 30 days-6 months +-7days
Adherence to pharmacological treatment by Morinsky Green Questionnaire, Dichotomous variable: yes means adherent to treatment wich is a better score and no means non adherent to treatment wich is a worse score.
0-2months +- 30 days-6 months +-7days
Quality of Life improvement
Time Frame: 0-2months +- 30 days-6 months +-7days

Quality of Life by EuroQol-5D questionnaire. EuroQoL-5D index (0-1) 0: Represent the worse state of Health, equivalent to death.

1: Represents the best state of Health ( no problems in any dimension of the questionnaire).
0-2months +- 30 days-6 months +-7days
Anxiety and depression
Time Frame: 0-2months +- 30 days-6 months +-7days

Anxiety and depression by Hospital Anxiety and Depression Scale (HADS). HAD Questionnaire:

0-42: Higher values are worse than lower values.
0-2months +- 30 days-6 months +-7days
Satisfaction rate
Time Frame: 2months +- 30 days
Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values
2months +- 30 days
Angioplasty revascularization procedure
Time Frame: 0-2months +- 30 days
Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better
0-2months +- 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost analysis
Time Frame: 6 months +-7days
Analyze in terms of economic cost (euros) whether there are differences between both programs ( total cost of Telerehabilitation program and total cost of in person program) Total cost includes: direct costs, indirect costs, and intangible costs.
6 months +-7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Germans Trias i Pujol Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI-21-286 (Other Identifier: Germans Trias i Pujol Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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