Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04593602
Status:
WITHDRAWN
Last Update Posted:
2023-03-10
First Post:
2020-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Mobilization in Older Adults With Acute Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The nature of the intervention requires randomization of entire units to the intervention with associated mobility culture change and this precludes a standard randomized controlled trial design (i.e., randomization of some patients to the intervention but not others). The stepped-wedge design allows each site to function as its own control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Changed research approach', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization', 'timeFrame': '1 month post-hospitalization', 'description': 'Health-related quality of life'}], 'secondaryOutcomes': [{'measure': 'SF-36 Physical Component Scale score', 'timeFrame': '12 months post-hospitalization', 'description': 'Health-related quality of life'}, {'measure': 'SF-36 Mental Component Summary score', 'timeFrame': '1 month post-hospitalization', 'description': 'Health-related quality of life'}, {'measure': 'SF-36 Mental Component Summary score', 'timeFrame': '12 months post-hospitalization', 'description': 'Health-related quality of life'}, {'measure': 'Level of Function Mobility Score', 'timeFrame': '1 month post-hospitalization', 'description': 'Functional status'}, {'measure': 'Level of Function Mobility Score', 'timeFrame': '12 months post-hospitalization', 'description': 'Functional status'}, {'measure': 'Hospital readmission', 'timeFrame': '1 month post-hospitalization', 'description': 'Resource use outcome'}, {'measure': 'Hospital readmission', 'timeFrame': '12 months post-hospitalization', 'description': 'Resource use outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Mobilization', 'Older Adults', 'Acute Cardiovascular Disease', 'Nursing']}, 'referencesModule': {'references': [{'pmid': '32739452', 'type': 'RESULT', 'citation': 'Semsar-Kazerooni K, Dima D, Valiquette J, Berube-Dufour J, Goldfarb M. Early Mobilization in People With Acute Cardiovascular Disease. Can J Cardiol. 2021 Feb;37(2):232-240. doi: 10.1016/j.cjca.2020.03.038. Epub 2020 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.', 'detailedDescription': 'The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic EM program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization. Nested cohort studies will explore (1) the relationship between EM, sedentary time, and posthospitalization outcomes and (2) the impact of EM on muscle mass loss and inflammation in older adults with acute CV disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 60 years\n* no planned cardiac surgery during admission\n\nExclusion Criteria:\n\n* projected cardiac ICU stays less than 24 hours\n* patients unable to complete follow-up'}, 'identificationModule': {'nctId': 'NCT04593602', 'acronym': 'EM-HEART', 'briefTitle': 'Early Mobilization in Older Adults With Acute Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Lady Davis Institute'}, 'officialTitle': 'Early Mobilization in Older Adults With Acute Cardiovascular Disease: A Prospective, Multi-centre Stepped Wedge Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'Lady Davis Institute'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Mobilization Intervention', 'description': "The bedside nurse determines the prehospital Level of Function based on patient and family report and current Level of Function based on nursing mobility assessment. Each Level of Function has 3 primary activities designed to promote the patient to the next level. The nurse leads mobility activities based on the patient's current Level of Function once per shift, twice daily (AM+PM). If a patient is able to complete each of the 3 activities, the nurse on the subsequent shift will assess whether the Level of Function can be advanced. Physiotherapy consultation is available if required, although not obligatory. Patients are encouraged to spend as much time in the chair and ambulatory as possible.", 'interventionNames': ['Behavioral: Early Mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Mobility Care', 'description': 'Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.', 'interventionNames': ['Behavioral: Usual Mobility Care']}], 'interventions': [{'name': 'Early Mobilization', 'type': 'BEHAVIORAL', 'description': 'Nurse-driven early mobilization activities twice daily', 'armGroupLabels': ['Early Mobilization Intervention']}, {'name': 'Usual Mobility Care', 'type': 'BEHAVIORAL', 'description': 'Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.', 'armGroupLabels': ['Usual Mobility Care']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Davis Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician-Investigator', 'investigatorFullName': 'Michael Goldfarb', 'investigatorAffiliation': 'Lady Davis Institute'}}}}