NCT04146727|Unknown
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Sponsor study identifier
observational
168
1 country
1
Study Start
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice. Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention. The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2019
Actual (reported)October 31, 2019
Actual (reported)January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Daily ambulation
Steps taken
From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Length of Stay
Days until Discharge to a transitional care facility vs. home
From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Admit again to ICU
Readmissions to an ICU or hospital
From date of inclusion until event or 30 days post enrollment
The total study duration is determined by their length of stay in the ICU.
Time from surgery through 1 month at home. Maximum duration is length of stay in the ICU plus 1 month at home.
Investigators and co-investigators will approach eligible subjects about the study in person after identification of patients in the intensive care unit or prior to surgery if it is not an emergent surgery. Some of the patients will be patients of other surgeons and intensivists who are part of the team-based care of these cardiac surgical patients.
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Anahat Dhillon, MD
Cedars-Sinai Medical Center
First Submitted
October 24, 2019
First Posted
October 31, 2019
Study Start
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
The Hepatitis C Transplant Collaborative
Contact the study team to confirm eligibility.
January 2021
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 31, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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