Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06807658
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2025-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost analysis', 'timeFrame': '6 months +-7days', 'description': '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.'}], 'primaryOutcomes': [{'measure': '% patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits', 'timeFrame': '• (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]', 'description': 'Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits\n\n1. Blood pressure \\<140/90 mmHg\n2. Maintaining normal weight or a 5% reduction in body weight if BMI \\> 25 kg/m2\n3. Abdominal circumference \\<88 cm in women and \\<102 cm in men\n4. LDL \\<50 mg/dl and a reduction of \\>50% in initial LDL levels\n5. Smoking cessation\n6. Adherence to a heart-healthy diet (PREDIMED Questionnaire\\* ≥7)\n7. Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ\\*\\* result (International Physical Activity Questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Adherence to cardiac rehabilitation program', 'timeFrame': '2 months +-30 day', 'description': '% of patients adherent to cardiac rehabilitation program'}, {'measure': 'Adherence to pharmacological treatment', 'timeFrame': '0-2months +- 30 days-6 months +-7days', 'description': '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.'}, {'measure': 'Quality of Life improvement', 'timeFrame': '0-2months +- 30 days-6 months +-7days', 'description': 'Quality of Life by EuroQol-5D questionnaire. EuroQoL-5D index (0-1) 0: Represent the worse state of Health, equivalent to death.\n\n1: Represents the best state of Health ( no problems in any dimension of the questionnaire).'}, {'measure': 'Anxiety and depression', 'timeFrame': '0-2months +- 30 days-6 months +-7days', 'description': 'Anxiety and depression by Hospital Anxiety and Depression Scale (HADS). HAD Questionnaire:\n\n0-42: Higher values are worse than lower values.'}, {'measure': 'Satisfaction rate', 'timeFrame': '2months +- 30 days', 'description': 'Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values'}, {'measure': 'Functional capacity', 'timeFrame': '0-2months +- 30 days', 'description': 'Functional capacity by cardiac stress test (METS)'}, {'measure': 'Cardiac cause hospitalization', 'timeFrame': '6 months +-7days', 'description': 'Cardiac cause hospitalization'}, {'measure': 'Emergency visits', 'timeFrame': '6 months +-7days', 'description': 'Emergency visits'}, {'measure': 'Angioplasty revascularization procedure', 'timeFrame': '0-2months +- 30 days', 'description': 'Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction (AMI)', 'Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarct prior to 2 months\n* Killip I-II classification\n* No previous myocardial infarction\n* No angina pectoris\n* No ischemia in complementary explorations\n* Normal arterial pressure response during stress test.\n* No relevant arrythmias\n* Left ventricular ejection fraction \\>= 35%\n* Functional capacity \\>5 METS\n* Signing of the inform consent\n\nExclusion Criteria:\n\n* Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program\n* Impossibility for digital media use'}, 'identificationModule': {'nctId': 'NCT06807658', 'acronym': 'TELECOR', 'briefTitle': 'Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome: Randomized Clinical Trial TELECOR Study', 'orgStudyIdInfo': {'id': 'PI-21-286'}, 'secondaryIdInfos': [{'id': 'PI-21-286', 'type': 'OTHER', 'domain': 'Germans Trias i Pujol Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tele-rehabilitation', 'description': '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.', 'interventionNames': ['Behavioral: Experimental: Cardiac tele-rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In person cardiac rehabilitation', 'description': '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.', 'interventionNames': ['Behavioral: Other: Control, in person cardiac rehabilitation']}], 'interventions': [{'name': 'Experimental: Cardiac tele-rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Patients will connect to their health care provider via a tele-call', 'armGroupLabels': ['Tele-rehabilitation']}, {'name': 'Other: Control, in person cardiac rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Patients will attend an ambulatory cardiac rehabilitation unit', 'armGroupLabels': ['In person cardiac rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'country': 'Spain', 'facility': 'Germans Trias i Pujol University Hospital', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}