A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03737149|
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Osteoarthritis, Hip||Other: mymobility with Apple Watch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a staged cohort study. In the first (pilot) cohort, all participating subjects will utilize the mymobility with Apple Watch platform. In the second (RCT) cohort, approximately 1,000 subjects will be randomized 1:1 to either the mymobility with Apple Watch platform or standard of care SOC. In the third (correlative analytics) cohort, all participating subjects will utilize the mymobility with Apple Watch platform.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: mymobility with Apple Watch
Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
Other: mymobility with Apple Watch
The mymobility mobile application is a mobile software platform designed to facilitate remote episode of care management and asynchronous communication between the provider care team and their patient via provider-approved care plans and engagement communications. Current care pathways have been developed for: Total Hip Replacement, Total Knee Replacement and Partial Knee Replacement. Designed for the orthopedic population, mymobility also integrates wearable data from the Apple Watch into provider dashboards, providing enhanced understanding and monitoring of patients throughout the episode of care.
No Intervention: Standard of Care Physical Therapy
Standard of care patient education and post-operative physical therapy, as determined by local site guidelines and care pathways.
- Phase II (RCT): Readmission Rate [ Time Frame: 30 Days postop ]RCT Phase: Non-inferiority of the mymobility with Apple Watch group in the number of readmissions through 30 days post-op compared to subjects receiving standard physical therapy.
- Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) [ Time Frame: 90 Days ]The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
- Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) [ Time Frame: 90 Days ]The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
- Phase II RCT: EQ-5D-5L [ Time Frame: 90 Days ]Non-inferiority in post-operative EQ-5D-5L outcomes for the mymobility with Apple Watch group compared to subjects receiving standard physical therapy.
- Phase II RCT: Incidence of Manipulation under Anesthesia (MUA) [ Time Frame: 90 Days ]Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
- Phase II RCT: Timed Up and Go (TUG) [ Time Frame: 90 Days ]Timed Up and Go Test: The time to rise from a chair, walk 10 feet, turn around, walk back to the chair and sit down.
- Phase II RCT: Single-Leg Stance (SLS) Test [ Time Frame: 90 Days ]Balance Test while standing on a single leg. Three tests are performed and the best of the three times is recorded. The maximum time for this test is 60 seconds.
- Phase II RCT: Subject Satisfaction [ Time Frame: 90 Days ]Comparison of subject satisfaction survey results between the study groups.
- Phase II RCT: Healthcare Costs [ Time Frame: 90 Days ]The number of hospital readmissions, reoperations, urgent care visits, and emergency room visits will be captured and used to calculate the cost of care after the joint replacement procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737149
|Contact: Scott Abshagen, BS, RN, CCRPfirstname.lastname@example.org|
|Contact: Hillary Overholseremail@example.com|
|Study Director:||Erin Osborn, MBA, CCRP||Zimmer Biomet|