Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-27 @ 5:34 AM
Study NCT ID:
NCT04858503
Status:
UNKNOWN
Last Update Posted:
2023-12-04
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000079102', 'term': 'Empowerment'}], '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'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-08', 'size': 536033, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-14T21:30', 'hasProtocol': True}, {'date': '2020-11-06', 'size': 733710, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-03T02:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 268}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-care behaviour', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute.'}], 'secondaryOutcomes': [{'measure': 'Biomarkers: lipid profile', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'POCT'}, {'measure': 'Physiological: blood pressure', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'Measure both systolic and diastolic blood pressure'}, {'measure': 'Anthropometric: waist-to-height ratio', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'Measure waist-to-height ratio'}, {'measure': 'Clinical: Cardiovascular event rates and mortality', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'the admissions, cardiovascular event rates and mortality data will be retrieved'}, {'measure': 'Self-reported health outcomes: functional status', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'The functional status will be measured with the Chinese version of Seattle Angina Questionnaire. This 19-item questionnaire consists of five subscales, including physical limitation, angina stability, angina frequency, treatment satisfaction and the disease perception. The respondents have to rate on a 1 to 5 or 6 sequentially coded status. The subscale scores are transformed to a scale of 0 to 100, with higher scores indicate higher level of functioning/ satisfaction and fewer limitations.'}, {'measure': 'Health-related Quality of life (HRQoL)', 'timeFrame': 'Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)', 'description': 'The Chinese version of MacNew will be used to measure disease-specific HRQoL.22 It consists of 27 items measuring HRQoL in three domains (physical, emotional and social). Each item is rated on a 1-7 scale, and a global score is calculated by summing the item scores, a higher score represents better HRQoL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-care', 'Model of care', 'Mobile app', 'Empowerment', 'Nurse-led', 'Disease Management', 'Risk factor control'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.", 'detailedDescription': "This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.\n\nCardiovascular disease, a highly prevalent morbidity, is the number one cause of death worldwide and has become a significant public health concern. The majority of these deaths are attributed to an acute manifestation of coronary artery disease (CAD), defined as a narrowing of the coronary arteries that causes insufficient myocardial blood flow. CAD has reached an unequivocal pandemic status globally and locally. CAD imposes not only significant physical and psychosocial burdens on patients, but also enormous service demands on healthcare systems.As a chronic condition, CAD requires patients to practice persistent self-care in a long-term manner for successful disease management. Self-care is considered fundamental to the prevention and management of chronic diseases. Yet, a significant proportion of the CAD population is still engaging in full-time employment, their time availability restricts them to participate in traditional health promotional activities. According to recent systematic reviews, substantial evidence has accumulated to support the positive effects of internet-delivered interventions. Therefore, an internet-based approach with self-care cardiac rehabilitation enhancement may be ab better method of engaging patients in the learning process and arousing their inherent capacities to maintain behavioral modifications. This mixed-method study consists of a two-arm randomized controlled trial and an exploratory qualitative study. For the randomized controlled trial plans to recruit 268 adults from Queen Mary Hospital and Care for Your Heart. Eligible participants will be CAD patients who aged 18 above, living in the community, owning a smartphone with internet access, communicable in Cantonese and able to type in Chinese or English. The participants will be randomly allocated to the intervention or control group to receive i-CARE or usual care, respectively. The study hypotheizes that the CAD patients who receive the i-CARE intervention will report better changes in self-care behaviours, blood pressure, cholesterols, waist-to-height ratio, functional status and HRQoL at 3 and 6 months after the intervention, than those who receive usual care and that the CAD patients who receive the i-CARE intervention will report fewer cardiovascular event rates and mortality at 6 months after the intervention, than those who receive usual care. The findings will advance our knowledge of the empirical effects of internet-based cardiac rehabilitation programme on CAD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* living in the community,\n* own a smartphone with internet access,\n* communicable in Cantonese,\n* type in Chinese or English,\n* with a confirmed diagnosis of CAD.\n\nExclusion Criteria:\n\n* enrolled to a structured centre-based or home-based cardiac rehabilitation program, (2) psychiatric problems,\n* impaired cognitive functioning (i.e. Abbreviated Mental Test ≤6), and\n* terminal disease with life expectancy \\< 1 year.'}, 'identificationModule': {'nctId': 'NCT04858503', 'briefTitle': 'An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease: A Mixed-method Study', 'orgStudyIdInfo': {'id': 'NTWC/REC/20139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'internet-based cardiac rehabilitation enhancement intervention', 'description': 'internet-based cardiac rehabilitation enhancement intervention', 'interventionNames': ['Other: internet-based cardiac rehabilitation enhancement intervention']}, {'type': 'NO_INTERVENTION', 'label': 'conventional cares as arranged by hospital or community centers', 'description': 'Participants will receive conventional cares as arranged by hospital or community centers'}], 'interventions': [{'name': 'internet-based cardiac rehabilitation enhancement intervention', 'type': 'OTHER', 'description': 'Participants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours.', 'armGroupLabels': ['internet-based cardiac rehabilitation enhancement intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Polly Li, Dr', 'role': 'CONTACT', 'email': 'pwcli@hku.hk', 'phone': '852-3917-6686'}], 'facility': 'The School of Nursing', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Polly Li, Dr', 'role': 'CONTACT', 'email': 'pwcli@hku.hk', 'phone': '852-39176686'}], 'overallOfficials': [{'name': 'Polly Li, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong, School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Polly Wai-Chi Li', 'investigatorAffiliation': 'The University of Hong Kong'}}}}