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

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: Completed
• Conditions: Cardiac Rehabilitation; Acute Myocardial Infarction (AMI)
• Intervention / Treatment: Behavioral: Experimental: Cardiac tele-rehabilitation; Behavioral: Other: Control, in person cardiac rehabilitation

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: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits; Blood pressure <140/90 mmHg; Maintaining normal weight or a 5% reduction in body weight if BMI > 25 kg/m2; Abdominal circumference <88 cm in women and <102 cm in men; LDL <50 mg/dl and a reduction of >50% in initial LDL levels; Smoking cessation; Adherence to a heart-healthy diet (PREDIMED Questionnaire* ≥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

Outcome Measure	Measure Description	Time Frame
Adherence to cardiac rehabilitation program	% of patients adherent to cardiac rehabilitation program	2 months +-30 day
Functional capacity	Functional capacity by cardiac stress test (METS)	0-2months +- 30 days
Cardiac cause hospitalization	Cardiac cause hospitalization	6 months +-7days
Emergency visits	Emergency visits	6 months +-7days
Adherence to pharmacological treatment	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	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	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	Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values	2months +- 30 days
Angioplasty revascularization procedure	Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better	0-2months +- 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost analysis	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

• Sponsor: Germans Trias i Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction; Acute Coronary Syndrome
• Other Study ID 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