Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT05071495
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MedDiet score (the Mediterranean diet score)', 'timeFrame': 'Up to 3 months', 'description': 'This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])', 'timeFrame': 'Up to 3 months'}, {'measure': 'Blood glycated hemoglobin (HbA1c) test', 'timeFrame': 'Up to 3 months'}, {'measure': 'Blood creatinine (Cr) test', 'timeFrame': 'Up to 3 months'}, {'measure': 'Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])', 'timeFrame': 'Up to 3 months'}, {'measure': 'Parameters in the ergospirometer test (anaerobic threshold [AT])', 'timeFrame': 'Up to 3 months'}, {'measure': 'Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])', 'timeFrame': 'Up to 3 months', 'description': 'This scale has the extreme values of 10 (minimum) and 40 (maximum). Higher scores mean a better outcome.'}, {'measure': 'Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])', 'timeFrame': 'Up to 3 months', 'description': 'This scale has the extreme values of 30 (minimum) and 150 (maximum). Higher scores mean a worse outcome.'}, {'measure': 'Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])', 'timeFrame': 'Up to 3 months', 'description': 'This scale has the extreme values of 0 (minimum) and 42 (maximum). Higher scores mean a better outcome.'}, {'measure': 'Body weight (BW)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Up to 3 months', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Secondary Prevention', 'Diet Therapy'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Digital cardiology is gaining power in the field of preventive cardiology recently, and several trials have already shown good results of dietary therapy with digital cardiology. However, there has been no reports that showed effect of dietary counseling through digital cardiology for secondary prevention of coronary artery disease.\n\nTeleDiet study investigates the impact of dietary therapy with a smartphone application on the content of meals and metabolic parameters for patients with coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Owning a smartphone and able to use it\n2. Written informed consent obtained\n3. Starting cardiac rehabilitation\n4. Coronary artery disease\n\nExclusion Criteria:\n\n1. Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)\n2. Age \\<18 years old\n3. Pregnancy'}, 'identificationModule': {'nctId': 'NCT05071495', 'briefTitle': 'TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'TeleDiet Study: A Randomized Controlled Study Investigating the Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2020/171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Device: Smartphone application']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Smartphone application', 'type': 'DEVICE', 'description': 'Smartphone application named "Signal", which connects patients and health providers', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Paul Dendale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jessa Ziekenhuis vzw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}