Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:50 PM
Study NCT ID:
NCT06071793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility - consent rate', 'timeFrame': 'Study duration - up to one year', 'description': 'We define a successful consent rate as \\> 70% of SDMs or patients approached to consent, agreeing to take part in the study'}, {'measure': 'Feasibility - recruitment rate', 'timeFrame': 'Study duration - up to one year', 'description': 'We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial'}, {'measure': 'Feasibility - protocol adherence', 'timeFrame': 'During ICU stay, censored at 1 month', 'description': 'We define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions'}, {'measure': 'Feasibility - resources', 'timeFrame': 'Study duration - up to one year', 'description': 'Physiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay.'}], 'secondaryOutcomes': [{'measure': 'Patient Delirium', 'timeFrame': 'During ICU stay, censored at 1 month', 'description': 'CAM-ICU'}, {'measure': 'Patient & Family PTSD symptoms', 'timeFrame': '1 & 3 months', 'description': 'IES-R'}, {'measure': 'Adverse Events', 'timeFrame': 'During ICU stay, censored at 1 month', 'description': 'Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries'}, {'measure': 'Family satisfaction', 'timeFrame': '1 & 3 months', 'description': '23-item Family Satisfaction in the ICU questionnaire; HADS scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Delirium']}, 'descriptionModule': {'briefSummary': "An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay.\n\nThe investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (≥18 years) in the ICU\n* Anticipated length of stay ≥48 hours for whom a request for physiotherapy has been placed by the treating physician\n* Appropriateness for physiotherapy confirmed by the unit's physiotherapist.\n* Families will be eligible if they are able to be present in ICU during physiotherapist or research team work hours until they are cleared to deliver activities independently, then at least three times weekly thereafter.\n\nExclusion Criteria:\n\n* Patients who are receiving end of life care\n* Patients who have high risk injuries including spinal cord injury or spinal fractures, post-operative from spinal surgery, and untreated hip or long bone fractures\n* Patients at risk of raised intracranial pressure (ICP) (e.g. Malignant middle cerebral artery stroke, large subarachnoid hemorrhage), admitted post trauma activation, post-operative from brain surgery or with external ventricular drain (EVD) in situ.\n* Patients who are bed-bound or require mechanical lift at baseline who would not otherwise be offered physiotherapy services.\n* Exclusion criteria for families include any major barriers to participation, i.e., physical, cognitive, emotional or capacity to understand and communicate with the team."}, 'identificationModule': {'nctId': 'NCT06071793', 'acronym': 'FIT-ICU', 'briefTitle': 'Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study', 'orgStudyIdInfo': {'id': '15669'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants', 'description': 'Patients to receive mobility interventions from trained family members', 'interventionNames': ['Other: Family involvement']}], 'interventions': [{'name': 'Family involvement', 'type': 'OTHER', 'description': 'Family delivery of mobility activities', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N3R 1G9', 'city': 'Brantford', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brant Community Healthcare System', 'geoPoint': {'lat': 43.1334, 'lon': -80.26636}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Kimberley Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Research Institute of St Joe's Hamilton"}, {'name': 'Laiya Carayannopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Research Institute of St Joe's Hamilton"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Intensivist', 'investigatorFullName': 'Kimberley Lewis', 'investigatorAffiliation': "St. Joseph's Healthcare Hamilton"}}}}