Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-28 @ 6:13 PM
Study NCT ID:
NCT05099692
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2021-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHD Patient's Concern on Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2021-10-16', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total number of different selected questions', 'timeFrame': '5 minutes', 'description': 'All participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. As a result, we calculate and collect the total number of different selected questions for each patients.'}, {'measure': 'The variety of different selected questions', 'timeFrame': '5 minutes', 'description': 'All participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. As a result, we calculate and collect the variety of different selected questions for each patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac rehabilitation', 'coronary heart disease', 'social-psychological factor'], 'conditions': ['Coronary Heart Disease', 'Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': "Our study focuses on the question about primary cardiac rehabilitation (CR) patients with coronary heart disease are concerned about demonstrating the association between the patients' view of CR and social associated factors. In our study, all participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. The selectable questions can be categorized into five titles: the content or purpose of CR, the method of CR, the advantage of CR, the adverse effect of CR, and the expenditure of CR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary heart disease eligible for the study must be at least 18 years of age or greater, able to participate in cardiac rehabilitation after medical judgments by the physicians for the first time and provide the written informed consent. Moreover, the participants must understand the questionnaire content and complete it.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\>18 years old\n* patients diagnosed as coronary heart disease\n* able to participate in cardiac rehabilitation after medical judgments for the first time\n* understand the questionnaire content\n* agree to participant in the study and provide the written informed consent\n\nExclusion Criteria:\n\n* unable to complete the questionnaire\n* patients who aren't willing or refuse to participate in the trial"}, 'identificationModule': {'nctId': 'NCT05099692', 'briefTitle': "CHD Patient's Concern on Cardiac Rehabilitation", 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': "CHD Patient' s Concern on Primary Cardiac Rehabilitation and Its Social Associated Factors", 'orgStudyIdInfo': {'id': 'N2021-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CHD patients participating in the cardiac rehabilitation', 'interventionNames': ['Behavioral: filling out the questionnaire']}], 'interventions': [{'name': 'filling out the questionnaire', 'type': 'BEHAVIORAL', 'description': 'all participants in our study are invited to choose at least 1 question in 15 questions or provide their own questions regarding their doubt about the CR after filling in their personal information', 'armGroupLabels': ['CHD patients participating in the cardiac rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Hu, Dr', 'role': 'CONTACT', 'email': 'huqiang071@foxmail.com', 'phone': '15291494943'}], 'facility': 'Qiang Hu', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Qiang Hu, Dr', 'role': 'CONTACT', 'email': 'huqiang071@foxmail.com', 'phone': '15291494943'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qiang Hu', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}