Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT05045118
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2021-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2021-09-01', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention rate', 'timeFrame': '3 months', 'description': 'The proportion of patients who completed the education material. The number of participants completed divided by the total number of participants, expressed in percentage'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': '3 months', 'description': 'Peak METs and HRmax measured by exercise stress testing, to estimate VO2 max. This measurement is recorded at pre and post 12 weeks of intervention'}], 'secondaryOutcomes': [{'measure': 'Smoking status', 'timeFrame': '3 months', 'description': 'Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program'}, {'measure': 'Compliance to medication', 'timeFrame': '3 months', 'description': 'Compliance to daily medication will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program'}, {'measure': 'Compliance to exercise', 'timeFrame': '3 months', 'description': 'Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischaemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the impact of providing a digital education material to participants of home based cardiac rehabilitation in improving clinical and behavioural outcomes', 'detailedDescription': 'This is a pilot study aiming to assess the impact of providing a structured patient education material in a digital form to participants of home based cardiac rehabilitation program in University Malaya Medical Centre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-70 years\n* Fulfills the low to moderate exercise participation risk criteria for Cardiac rehabilitation program phase 2 as per the American Association of Cardiovascular and Pulmonary Rehabilitation standards\n* Able to participate in a treadmill exercise program\n* Cognitively able to give consent, and able to read and utilize the digital education material\n\nExclusion Criteria:\n\n* Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards'}, 'identificationModule': {'nctId': 'NCT05045118', 'briefTitle': 'The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study', 'orgStudyIdInfo': {'id': 'MREC ID: 20201010-9146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material', 'interventionNames': ['Other: Digital Structured Patient Education Material']}], 'interventions': [{'name': 'Digital Structured Patient Education Material', 'type': 'OTHER', 'description': 'Participants of home-based Cardiac Rehabilitation Program that are included in this research will be provided with a digital Structured Patient Education Material at the beginning of the program, and will be followed up for 12 weeks duration', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Anie Farhana Ngimron, MBBChBAO', 'role': 'CONTACT', 'email': 'aniefarhana@ummc.edu.my', 'phone': '+60136228602'}, {'name': 'Anwar Suhaimi, MD, MRehabMed', 'role': 'CONTACT', 'email': 'anwar@ummc.edu.my', 'phone': '+60166591383'}, {'name': 'Anie Farhana Ngimron, MBBChBAO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anwar Suhaimi, MD, MRehabMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}