Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-14 @ 11:15 AM
Study NCT ID:
NCT02674503
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of a Mobility Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alayne.markland@va.gov', 'phone': '205-558-7067', 'title': 'Dr. Alayne Markland', 'organization': 'Birmingham VA - GRECC Director; Professor at UAB'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study recruitment did not meet the calculated sample size target of 258 participants.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.\n\nWalking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 11, 'seriousNumAtRisk': 60, 'deathsNumAffected': 10, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Friendly Visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.\n\nFriendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 24, 'seriousNumAtRisk': 68, 'deathsNumAffected': 9, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'skin irritation', 'notes': 'Skin irritation at site for step watch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Emergency Department visits', 'notes': 'Visit to ED after initial hospital stay over a 6 month period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 37, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 41, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rehospitalization', 'notes': 'Readmission to the hospital in the 6-month period after the initial hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 36, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Life-Space Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.\n\nWalking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.'}, {'id': 'OG001', 'title': 'Friendly Visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.\n\nFriendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '23.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Linear fixed effect models adjusted for time in months', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'One year', 'description': 'The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. The range in scores is 0-100 with higher scores representing better life space mobility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Adverse Outcomes: Rehospitalization', 'timeFrame': 'One Year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of rehospitalization in the MP versus UC groups.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Presence of Adverse Outcomes: Nursing Home Placement', 'timeFrame': 'One year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of nursing home placement in the MP versus UC groups.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Presence of Adverse Outcomes: Death', 'timeFrame': 'One year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of death in the MP versus UC groups.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Activities of Daily Living (ADLs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.\n\nWalking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.'}, {'id': 'OG001', 'title': 'Friendly Visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.\n\nFriendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.34', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear effects model adjusted for time (in months)'}], 'paramType': 'MEAN', 'timeFrame': 'One Year', 'description': 'Participants will be asked to complete the Katz ADL. Specifically, patients will be asked to rate their current level of independence with six activities of daily living (feeding, bathing, dressing, toileting, transferring, and walking across a small room). Scores range from 0-12, with lower scores representing better independence in activities of daily living.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Adverse Outcomes (ED Visits, Rehospitalization, Nursing Home Placement, Death)', 'timeFrame': 'One year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of ED visits, hospitalizations as well as death and nursing home admissions including both short and long term placement in the MP versus UC groups.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Instrumental Activities of Daily Living (IADLs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.\n\nWalking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.'}, {'id': 'OG001', 'title': 'Friendly Visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.\n\nFriendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed effects models adjusted for time (in months)'}], 'paramType': 'MEAN', 'timeFrame': 'One year', 'description': 'Level of independence with Instrumental Activities of Daily Living (IADLs) will be assessed at the same time points as the basic ADLs using the Lawton Index. The IADL index evaluates 8 domains of function including shopping, food preparation, housekeeping, laundry, transportation, handling finances, ability to take own medications and use of the telephone. A summary score ranges from 3 to 24, with higher scores indicating higher levels of independence with the tasks. Score options were trichotomous (1 = unable, 2 = needs assistance, 3 = independent).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mini Cognitive Assessment (Mini-Cog)', 'timeFrame': 'Baseline only', 'description': 'The Mini-Cog is a brief cognitive screening measure that includes a three-item memory recall and a clock drawing test. The test is scored using a simple algorithm whereby patients who are unable to recall any of the three items are considered demented; those who can recall all three items are deemed not demented; and those with intermediate word recall ability (1 or 2 items) are classified based on the clock drawing test. For persons with intermediate recall ability, if the clock drawing is abnormal, the patient is considered demented and if the clock drawing is normal the patient is not considered demented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Confusion Assessment Method', 'timeFrame': 'Baseline only', 'description': 'The Confusion Assessment Method (CAM) allows rapid assessment of the presence of delirium. Four clinical features, including 1) Acute onset and fluctuating course; 2) Inattention; 3) Disorganized thinking; and 4) Altered level of consciousness, are assessed. The presence of features 1 and 2 and either 3 or 4 indicates the patient has delirium. The positive and negative predictive values for the CAM are approximately 90%.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ) -2', 'timeFrame': 'One year', 'description': 'Patients will be asked at each interview the Patient Health Questionnaire (PHQ) - 2, specifically 1) Have you often been bothered by feeling down, depressed, or hopeless?; and 2) Have you often been bothered by little interest or pleasure in doing things? The PHQ-2 has been found to have a sensitivity and specificity of 83% and 92% respectively and is an excellent brief screening tool for depression.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'EuroQOL Five Dimensions Questionnaire (EQ-5D)', 'timeFrame': 'One year', 'description': 'Patients will be asked to complete the EQ-5D once during the hospital stay, then at months 1, 3, 6, 9, and 12. The EQ-5D-3L is a well-validated measure of quality of life which enables the calculation of a single index value ranging from 0, worst imaginable health to 1, perfect health.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Lubben Social Network Scale (LSNS-Revised)', 'timeFrame': 'One year', 'description': 'The Lubben Social Network Scale (LSNS) was designed to measure perceived social support received from family and friends. The LSNS-Revised includes 12 items with scores ranging from 0-60 with higher scores indicating greater perceived social support.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Level of Hospital Mobility', 'timeFrame': 'Average one week', 'description': 'All patients will wear a StepWatch throughout the hospitalization to document the level of mobility attained by each patient. The StepWatch is a ankle worn pedometer that documents number of steps taken and when they were taken.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.\n\nWalking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.'}, {'id': 'FG001', 'title': 'Friendly Visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.\n\nFriendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Dates of recruitment were 12/12/2016 through 10/19/2019. Participant recruited from the inpatient hospital setting.', 'preAssignmentDetails': 'No significant events in the study that occurred after participant enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.\n\nWalking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.'}, {'id': 'BG001', 'title': 'Friendly Visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.\n\nFriendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.2', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Life Space Total Score, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.1', 'spread': '28.3', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '23.2', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '25.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The range in scores is 0-100 with higher scores representing better life space mobility.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data on n=1 for this measure; not able to calculate score due to missing data'}, {'title': 'Activities of Daily Living Score, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0-12, with lower scores representing better independence in activities of daily living.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data on n=18 for this measure; not able to calculate score due to missing data'}, {'title': 'Instrumental Activities of Daily Living Score, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '14.8', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A summary score ranges from 3 to 24, with higher scores indicating higher levels of independence with the tasks. Score options were trichotomous (1 = unable, 2 = needs assistance, 3 = independent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '2 participants in each group did not get randomized, n=4 without baseline data'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-05', 'size': 1434506, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-10T15:15', 'hasProtocol': True}, {'date': '2017-10-25', 'size': 125351, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-10T15:29', 'hasProtocol': False}, {'date': '2017-10-25', 'size': 3276633, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-19T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2016-01-08', 'resultsFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-26', 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life-Space Assessment Score', 'timeFrame': 'One year', 'description': 'The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. The range in scores is 0-100 with higher scores representing better life space mobility.'}], 'secondaryOutcomes': [{'measure': 'Presence of Adverse Outcomes: Rehospitalization', 'timeFrame': 'One Year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of rehospitalization in the MP versus UC groups.'}, {'measure': 'Presence of Adverse Outcomes: Nursing Home Placement', 'timeFrame': 'One year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of nursing home placement in the MP versus UC groups.'}, {'measure': 'Presence of Adverse Outcomes: Death', 'timeFrame': 'One year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of death in the MP versus UC groups.'}, {'measure': 'Activities of Daily Living (ADLs)', 'timeFrame': 'One Year', 'description': 'Participants will be asked to complete the Katz ADL. Specifically, patients will be asked to rate their current level of independence with six activities of daily living (feeding, bathing, dressing, toileting, transferring, and walking across a small room). Scores range from 0-12, with lower scores representing better independence in activities of daily living.'}, {'measure': 'Presence of Adverse Outcomes (ED Visits, Rehospitalization, Nursing Home Placement, Death)', 'timeFrame': 'One year', 'description': 'To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of ED visits, hospitalizations as well as death and nursing home admissions including both short and long term placement in the MP versus UC groups.'}, {'measure': 'Instrumental Activities of Daily Living (IADLs)', 'timeFrame': 'One year', 'description': 'Level of independence with Instrumental Activities of Daily Living (IADLs) will be assessed at the same time points as the basic ADLs using the Lawton Index. The IADL index evaluates 8 domains of function including shopping, food preparation, housekeeping, laundry, transportation, handling finances, ability to take own medications and use of the telephone. A summary score ranges from 3 to 24, with higher scores indicating higher levels of independence with the tasks. Score options were trichotomous (1 = unable, 2 = needs assistance, 3 = independent).'}, {'measure': 'Mini Cognitive Assessment (Mini-Cog)', 'timeFrame': 'Baseline only', 'description': 'The Mini-Cog is a brief cognitive screening measure that includes a three-item memory recall and a clock drawing test. The test is scored using a simple algorithm whereby patients who are unable to recall any of the three items are considered demented; those who can recall all three items are deemed not demented; and those with intermediate word recall ability (1 or 2 items) are classified based on the clock drawing test. For persons with intermediate recall ability, if the clock drawing is abnormal, the patient is considered demented and if the clock drawing is normal the patient is not considered demented.'}, {'measure': 'Confusion Assessment Method', 'timeFrame': 'Baseline only', 'description': 'The Confusion Assessment Method (CAM) allows rapid assessment of the presence of delirium. Four clinical features, including 1) Acute onset and fluctuating course; 2) Inattention; 3) Disorganized thinking; and 4) Altered level of consciousness, are assessed. The presence of features 1 and 2 and either 3 or 4 indicates the patient has delirium. The positive and negative predictive values for the CAM are approximately 90%.'}, {'measure': 'Patient Health Questionnaire (PHQ) -2', 'timeFrame': 'One year', 'description': 'Patients will be asked at each interview the Patient Health Questionnaire (PHQ) - 2, specifically 1) Have you often been bothered by feeling down, depressed, or hopeless?; and 2) Have you often been bothered by little interest or pleasure in doing things? The PHQ-2 has been found to have a sensitivity and specificity of 83% and 92% respectively and is an excellent brief screening tool for depression.'}, {'measure': 'EuroQOL Five Dimensions Questionnaire (EQ-5D)', 'timeFrame': 'One year', 'description': 'Patients will be asked to complete the EQ-5D once during the hospital stay, then at months 1, 3, 6, 9, and 12. The EQ-5D-3L is a well-validated measure of quality of life which enables the calculation of a single index value ranging from 0, worst imaginable health to 1, perfect health.'}, {'measure': 'Lubben Social Network Scale (LSNS-Revised)', 'timeFrame': 'One year', 'description': 'The Lubben Social Network Scale (LSNS) was designed to measure perceived social support received from family and friends. The LSNS-Revised includes 12 items with scores ranging from 0-60 with higher scores indicating greater perceived social support.'}, {'measure': 'Level of Hospital Mobility', 'timeFrame': 'Average one week', 'description': 'All patients will wear a StepWatch throughout the hospitalization to document the level of mobility attained by each patient. The StepWatch is a ankle worn pedometer that documents number of steps taken and when they were taken.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Walking', 'Hospitalization', 'Randomized controlled trial'], 'conditions': ['Hospitalization']}, 'descriptionModule': {'briefSummary': 'After hospitalization, many older adults experience more difficulty getting around in the community and performing one or more of their basic activities of daily living (ADLs) like bathing or dressing. The goals of this study are to test the effectiveness of a mobility intervention, compared to usual care, on change in mobility after hospitalization, to determine the impact on one-year outcomes such as nursing home placement and to identify which Veterans benefit the most from the intervention. Ultimately, the goal is to improve recovery after hospitalization and reduce disability in hospitalized Veterans.', 'detailedDescription': 'For this high impact study the investigators propose to use a stepped wedge cluster randomization design on five VA hospital wards to compare a mobility program (MP) to usual care (UC) among a cohort of Veterans age 50 years. The investigators will examine pre to post-hospital mobility and adverse outcomes including functional decline, nursing home admission, emergency department (ED) visits, hospitalization and death in the MP and UC groups in the year after hospital discharge. The primary outcome of mobility will be measured by the University of Alabama at Birmingham (UAB) Life-Space Assessment (LSA).10-13 Secondary measures of mobility will include self-reported ability to walk mile and drive a car, as described by Gill, et al.14 The investigators will identify patient specific characteristics that modify the effect of the mobility intervention on post-hospital mobility and adverse outcomes to determine which hospitalized patients are most likely to benefit from this intervention.\n\nNote, Secondary outcome measures were curtailed as the original PI, Dr. Brown, retired.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 years admitted to one of the five hospital wards of the Birmingham VA Medical Center (VAMC) for any medical illness, e.g.:\n\n * Pneumonia\n * Heart failure\n * Chronic obstructive pulmonary disease (COPD) exacerbation\n * Or other medical (versus surgical) indication for hospitalization\n* Patients will be recruited within 48 hours of hospitalization, followed throughout their hospitalization and for one year after hospital discharge.\n\nExclusion Criteria:\n\n* Patients admitted for brief observation will be excluded, e.g.:\n\n * 23-hour observation for possible myocardial infarction\n * Additional exclusion criteria will include:\n * Inability to walk across a small room 2 weeks prior to admission\n * Inability to walk safely with assistance, based on a strength and balance screen (see Training of Walkers, below for details)\n * Having a pulmonary embolus, unstable angina or other medical diagnosis deemed by the primary physician to be a contraindication to walking\n * Being on hospice or comfort care\n * Being in a semi-private room with another currently enrolled participant\n * Non-English speaking, blind, or deaf'}, 'identificationModule': {'nctId': 'NCT02674503', 'briefTitle': 'Impact of a Mobility Program', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Impact of a Hospital Mobility Program on Function After Discharge', 'orgStudyIdInfo': {'id': 'E1995-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.', 'interventionNames': ['Behavioral: Walking']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Friendly visit', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.', 'interventionNames': ['Behavioral: Friendly visit']}], 'interventions': [{'name': 'Walking', 'type': 'BEHAVIORAL', 'description': 'MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.', 'armGroupLabels': ['Intensive']}, {'name': 'Friendly visit', 'type': 'BEHAVIORAL', 'description': 'UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.', 'armGroupLabels': ['Friendly visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham VA Medical Center, Birmingham, AL', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Cynthia J Brown, MD MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Birmingham VA Medical Center, Birmingham, AL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'No detailed plans at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}