Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT04206306
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2018-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Recovery Over the First Year After ICU Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time spent administering delirium tools', 'timeFrame': 'time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system', 'description': 'time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system'}, {'measure': 'Diagnostic accuracy of HGS and MIP as surrogate markers for ICU-AW', 'timeFrame': 'Baseline at ICU discharge', 'description': 'Measured by the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).'}], 'primaryOutcomes': [{'measure': 'Change from baseline 6-min walking distance to one year after ICU discharge', 'timeFrame': 'Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge', 'description': 'Measured by distance walked in 6 minutes(6MWT) in meter'}, {'measure': 'Change from baseline hand grip strength to one year after ICU discharge', 'timeFrame': 'Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge', 'description': 'Measured by hand grip strength (HGS) in kg, range from 20 to 65 kg, higher value indicated better musculoskeletal function'}, {'measure': 'Maximum inspiratory pressure, from baseline to one year after ICU discharge', 'timeFrame': 'Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge', 'description': 'Measured by maximum inspiratory pressure (MIP test ) in cmH2O, normal range \\< -20 cmH2O, lower value indicated better respiratory muscle condition'}, {'measure': 'Change from baseline Mini-Mental State Examination to one year after ICU discharge', 'timeFrame': 'Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge', 'description': 'Measured by Mini-Mental State Examination (MMSE) in score, range from 0 to 30 score, higher score indicated better cognitive function'}, {'measure': 'Physical function', 'timeFrame': 'Three months after ICU discharge', 'description': 'Measured by Physical function ICU test score (PFITs)'}, {'measure': 'Activities of daily living score, from baseline to one year after ICU discharge', 'timeFrame': 'Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge', 'description': 'Measured by basic activities of daily living (ADL) in score, range from 0-100 score, higher score indicated health condition'}, {'measure': 'Instrumental activities of daily living score, from baseline to one year after ICU discharge', 'timeFrame': 'Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge', 'description': 'Measured by instrumental activities of daily living (IADL) in score, range from 0 to 8 score, higher score indicated better health condition'}, {'measure': 'Scores of Medical Research Council (MRC) scale, from baseline to one year after ICU discharge', 'timeFrame': 'Baseline at ICU discharge. One year after ICU discharge', 'description': 'Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength'}, {'measure': 'Self-report MRC questionnaire score', 'timeFrame': 'At ICU discharge one month', 'description': 'range from 0 to 60, score greater than or equal to 48, classified as no muscle weakness'}, {'measure': 'Sit-to-stand ability (yes/no)', 'timeFrame': 'Three months after ICU discharge', 'description': 'Asking participants to rise from a seated position, with full body weight on the chair, to a standing posture, with their legs fully extended.'}], 'secondaryOutcomes': [{'measure': 'ICU, hospital, and one-year mortality', 'timeFrame': 'death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record', 'description': 'death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record'}, {'measure': 'Length of ICU and hospital stay (day)', 'timeFrame': 'calculated a duration of ICU and hospitalization, obtained by medical record', 'description': 'calculated a duration of ICU and hospitalization, obtained by medical record'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Unit Acquired Delirium', 'Intensive Care Unit Survivor', 'Intensive Care Unit Acquired Weakness', 'Functional recovery'], 'conditions': ['Adult Patients', 'Intensive Care Unit']}, 'referencesModule': {'references': [{'pmid': '39468861', 'type': 'DERIVED', 'citation': 'Siao SF, Zheng YY, Wei YC, Boehm LM, Chen CC. Delirium and Weakness Acquired in the Intensive Care Unit: Individual and Combined Effects on 90-Day Mortality in Survivors of Critical Illness. J Clin Nurs. 2025 Sep;34(9):3620-3627. doi: 10.1111/jocn.17517. Epub 2024 Oct 29.'}]}, 'descriptionModule': {'briefSummary': "Intensive Care Unit Acquired Delirium (ICU-AD) and Intensive Care Unit Acquired Weakness (ICU-AW) are common in critically ill, mechanically ventilated adult patients. As more patients survive ICU stays but suffer from long-term functional declines leading to unemployment and disability, research is urgently needed. The aims of this study are to: 1) describe the trajectory of physical functions one year after ICU discharge, including distance walked in 6 minutes (6MWD), hand grip (HGS), maximum inspiratory pressure (MIP), cognitive function (mini mental state examination,MMSE), physical function ICU test score (PFITs) , medical reserach council scale (MRC), medical research council questionnaire (MRC-Q)and basic and instrumental activities of daily living (ADL/IADL); 2) examine the incidences of ICU-AD and ICU-AW; and 3) test the interaction between ICU-AD and ICU-AW on one-year functional trajectories in the ICU survivors.4) compare two tools, the intensive care delirium screening checklist (ICDSC) and confusion assessment method for the ICU (CAM-ICU), for their predictive validity for outcomes related to delirium, hospital mortality and length of stay (LOS), and examined whether the tools' predictive validity was affected by patients' arousal status (RASS≥0, RASS\\<0).", 'detailedDescription': "For this 3-year cohort study, consecutive ICU stay over 24 hours and adult patients (≧20 years) will be screened for enrollment at 6 medical ICUs in the National Taiwan University Hospital. Participants will be assessed daily for delirium occurrence for up to 14 days of ICU stay, and again upon ICU discharge. The instrument used for delirium are the confusion assessment method for ICU (CAM-ICU) and the intensive care delirium screening checklist (ICDSC). The 7 point rating scale of CAM-ICU-7 will also be used to rate the severity of delirium. Delirium assessment is possible,if the the patient's Richmond Agitation and Sedation Scale (RASS, -5\\~+4) is ≧ -3, -4\\~-5 are deeper levels of sedation (unarousable or responsive to painful stimulation only) cannot be assessed accurately. The CAM-ICU comprises four features which assess the following: acute change or fluctuation in mental status (Feature 1), inattention (Feature 2), disorganized thinking (Feature 3) or an altered level of consciousness (Feature 4). Patients are considered to have delirium if they present with both the first (acute onset and fluctuating course) and second (inattention) core symptoms and either the third (altered consciousness) or fourth (disorganized thinking) symptom. The ICDSC comprises eight items (score 0-8), ICDSC score of 4 or higher are considered delirium.\n\nAt ICU discharge,assess ICU-AW using a standardized protocol. Participants will be followed for one year after ICU discharge at 1, 3, 6, 12 months. A comprehensive functional evaluation (6-minute walking test, grip strength test, maximum inspiratory pressure test, mini-mental state exam, physical function ICU test score and basic and instrument activities of daily living questionnaires, medical research council scale and medical research council questionnaire) will be completed. Estimated 158 participants will be enrolled and followed for one year.\n\nData will be analyzed using the SPSS package. For example, the Generalized Estimating Equation (GEE) will be performed to delineate the trajectory of physical functions one year after ICU discharge and to test the interaction among ICU-AD, ICU-AW, and one-year functional trajectories. The findings will add to the development of intervention program to reduce ICU-AD and ICU-AW, thus promoting functional recovery for ICU survivors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive about patients (≧20 years) admitted to the six medical intensive care units at the National Taiwan University Hospital (NTUH).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is 20 years or older.\n\nExclusion Criteria:\n\n* patients who presented with preexisting delirium at ICU admission\n* patients who were placed on contact and droplet precaution\n* patient who is long-term bedridden, moderate to severe dementia\n* expected ICU length of stay less than 24 hours\n* unable to communicate in Mandarin or Taiwanese\n* unable to follow command completely'}, 'identificationModule': {'nctId': 'NCT04206306', 'briefTitle': 'Functional Recovery Over the First Year After ICU Discharge', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact', 'orgStudyIdInfo': {'id': '201802070RIND'}}, 'contactsLocationsModule': {'locations': [{'zip': '10055', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Cheryl Chia-Hui Chen Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Nursing, College of Medicine, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}