Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-02 @ 3:38 AM
Study NCT ID:
NCT04271566
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body mass index', 'timeFrame': '9 months', 'description': 'Body mass index for all patients'}], 'primaryOutcomes': [{'measure': 'HRQOL measured by RAND-Short form (SF)- 36 questionnaire', 'timeFrame': '9 months', 'description': 'Health related quality of life to be measured using RAND-Short form (SF)- 36 questionnaire. This questionnaire comprises of 36 questions that measure HRQOL across 8 different domains that can be summarised into physical, mental and general health summary scores. Higher the SF 36 domain scores, better is the quality of life.'}], 'secondaryOutcomes': [{'measure': 'Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form', 'timeFrame': '9 months', 'description': 'Physical activity of the participants to be measured using International Physical Activity Questionnaire (IPAQ)- Short Form. It measures physical vigorous and moderate physical activity along with time spent in walking and sedentary activities. Higher the IPAQ score, higher is the physical activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34741536', 'type': 'DERIVED', 'citation': 'Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.'}]}, 'descriptionModule': {'briefSummary': 'This study has two parts: A drug utilization study and a Health-related quality of life study.', 'detailedDescription': 'This study has two parts: A drug utilization study and a Health-related quality of life study.\n\nDrug utilisation study is an open label, cross sectional, descriptive drug utilization analysis of the primary cardiovascular drug classes prescribed to coronary artery disease patients attending cardiology OPD of a North India hospital.\n\nQuality of life study intended to evaluate impact of a mobile based patient education program on the health related quality of life, physical activity and body mass index of coronary artery disease patients. It is a two arm study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults 18 - 75 years of age\n* Diagnosed cased of coronary artery disease\n* Agreeing after informed consent to participate\n\nExclusion Criteria:\n\n* High risk cardiac patients\n* Systemic, orthopedic and/or neurological problems restricting physical activity'}, 'identificationModule': {'nctId': 'NCT04271566', 'briefTitle': 'Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic', 'organization': {'class': 'OTHER', 'fullName': 'KR Mangalam University'}, 'officialTitle': 'Drug Utilization and Quality of Life Study in Coronary Artery Disease Patients in a North Indian Tertiary Care Center', 'orgStudyIdInfo': {'id': 'HappyHeartTrial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Patients receiving an education program along with usual medical care', 'interventionNames': ['Behavioral: Education program']}, {'type': 'NO_INTERVENTION', 'label': 'Non Experimental', 'description': 'Patients receiving usual medical care'}], 'interventions': [{'name': 'Education program', 'type': 'BEHAVIORAL', 'description': 'A mobile application plus short message service (SMS) program to deliver disease-related health education and reinforcement to experimental group patients and see its impact on their health related quality of life, physical activity and Body mass index', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '122002', 'city': 'Gurgaon', 'state': 'Haryana', 'country': 'India', 'facility': 'Paras Hospital', 'geoPoint': {'lat': 28.4601, 'lon': 77.02635}}], 'overallOfficials': [{'name': 'Yojna Jain, Masters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KR Mangalam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KR Mangalam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scholar', 'investigatorFullName': 'Yojna Sah Jain', 'investigatorAffiliation': 'KR Mangalam University'}}}}