Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-06-18 @ 3:29 PM
Study NCT ID:
NCT06776159
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Standardizing Procedures for SC Injections of LMWH on Patients With CVD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003288', 'term': 'Contusions'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The administrative staff, who will be responsible for data collection, will be masked for the group allocation during the whole process. The patients will be masked for the intervention purpose.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded, two-armed, clustered randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bruising', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'The bruising diameter will be measured by a ruler and the incidence of bruising will be recorded.'}, {'measure': 'Pain', 'timeFrame': 'Immediately after injection, 24 hours, 48 hours, 72 hours', 'description': "Patients' pain levels are assessed using the Verbal Descriptor Scale: 'severe pain,' 'moderate pain,' 'mild pain,' and 'no pain.' 'Severe pain' indicates the worst outcome, followed by 'moderate pain,' then 'mild pain,' with 'no pain' representing the best outcome."}], 'secondaryOutcomes': [{'measure': 'Patient Experience', 'timeFrame': 'Immediately after receiving the injection', 'description': "a Patient Experience Surveys to evaluate their perceived nurse's attitude"}, {'measure': 'Communicative Competence', 'timeFrame': 'Immediately before and after injection', 'description': 'Communicative Competence Scale consists of 36 items across five dimensions (General Competence, Empathy Affiliation/Support, Behavioural Flexibility, and Social Relaxation), using a 5-point Likert scales ranging from strongly agree to strongly disagree (coded from 1 to 5). Higher the score means worse the outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LMWH injection'], 'conditions': ['CVD - Cardiovascular Disease', 'Bruise', 'Pain']}, 'descriptionModule': {'briefSummary': 'Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.', 'detailedDescription': 'This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day\n* Chinese\n\nExclusion Criteria:\n\n* cognitively impaired\n* unconscious\n* refuse to participate'}, 'identificationModule': {'nctId': 'NCT06776159', 'acronym': 'LMWH', 'briefTitle': 'The Effect of Standardizing Procedures for SC Injections of LMWH on Patients With CVD', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients With Cardiovascular Diseases: A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20250301'}, 'secondaryIdInfos': [{'id': 'CHEUNGPuiYu', 'type': 'OTHER', 'domain': 'Hong Kong PolyU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'The control group participants will receive the usual practice of subcutaneous LMWH injection administered by nurses.', 'interventionNames': ['Other: Active Control']}, {'type': 'EXPERIMENTAL', 'label': 'Standardized injection protocol', 'description': 'The intervention group participants will receive standardized LMWH injection administered by nurses.', 'interventionNames': ['Other: Standardized injection protocol']}], 'interventions': [{'name': 'Active Control', 'type': 'OTHER', 'description': 'Patients in the control group will receive the usual practice of subcutaneous LMWH injection administered by nurses.', 'armGroupLabels': ['Active Control']}, {'name': 'Standardized injection protocol', 'type': 'OTHER', 'description': 'Nurses administer LMWH according to the standardized evidence-based protocol.', 'armGroupLabels': ['Standardized injection protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'facility': 'Hospital Authority, Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Frankie CHEUNG', 'role': 'CONTACT', 'email': 'frankie.py.cheung@polyu.edu.hk', 'phone': '852 2766 7991'}, {'name': 'Arkers Wong', 'role': 'CONTACT', 'email': 'arkers.wong@polyu.edu.hk', 'phone': '852 3400 3805'}], 'overallOfficials': [{'name': 'Arkers Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Practice', 'investigatorFullName': 'CHEUNG Pui Yu Frankie', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}