Automated Hovering for Joint Replacement Surgery
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ClinicalTrials.gov Identifier: NCT03435549 |
Recruitment Status :
Completed
First Posted : February 19, 2018
Last Update Posted : July 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Joint Disease | Behavioral: Remote monitoring Behavioral: Remote monitoring plus goal setting and social support | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Health Services Research |
Official Title: | Automated Hovering for Joint Replacement Surgery |
Actual Study Start Date : | February 7, 2018 |
Actual Primary Completion Date : | April 12, 2019 |
Actual Study Completion Date : | April 12, 2019 |

Arm | Intervention/treatment |
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No Intervention: Arm 1: Control Arm (Usual care)
If Patient is randomized to Arm 1, no contact will occur, patient will receive standard and routine clinical care
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Experimental: Arm 2a: Remote monitoring
If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery
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Behavioral: Remote monitoring
Patients given an activity tracker to wear for 6 weeks after LEJR replacement surgery. For 2 weeks after surgery, they will also receive a daily text messages asking what their pain is on a scale of 0 to 10. They will be asked to reply to the text with their pain score. They will also be sent occasional messaging about their recovery, tips of what to do, and feedback on their progress. They will also also be sent a text message if they stop using their activity tracker for 3 days. |
Experimental: Arm 2b: Remote monitoring plus goal setting and social support
If Patient is randomized to Arm 2b, they will receive a remote monitoring plus social support and nudge messaging for 6 weeks post-surgery
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Behavioral: Remote monitoring plus goal setting and social support
Patients given activity tracker to wear for 6 weeks after LEJR surgery. For 2 weeks after surgery, they will receive a daily text messages asking what their pain is on a scale of 0 to 10 and asked to reply by text. They will be sent occasional messaging about their recovery, tips of what to do, and feedback on their progress. They will also also be sent a text message if they stop using their activity tracker for 3 days. Patients will be asked to identify a a friend or family member to act as support partner. The study will share progress updates with support partner and contact this individual if patient stops wearing the activity tracker for over 3 days. This partner will also be able to provide supportive messages to help encourage them to reach their activity goals. |
- Discharged to home [ Time Frame: Day of discharge through study completion at 6 weeks ]% of patients discharged to home
- Step increase [ Time Frame: 6 weeks post discharge ]% of step increase as measured by activity tracker
- Days spent at home [ Time Frame: 6 weeks post discharge ]Number of days spent at home after discharge
- Timed Up and Go (TUG) score [ Time Frame: 6 weeks post discharge ]% change in TUG score

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eligibility Criteria: University of Pennsylvania Health System (UPHS) patients between the ages of 18-85 with a Risk Assessment and Prediction Tool (RAPT) of 6-8 and scheduled to undergo primary lower-extremity joint replacement surgery.
Exclusion Criteria:
- Patients will be excluded if they do not meet all of the inclusion criteria, or if they have bilateral or revision surgery, dementia, end stage renal disease, cirrhosis, metastatic cancer, non- English speaker, or other physical impairment (ex. amputation)

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): NCT03435549
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Shivan Mehta, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT03435549 |
Other Study ID Numbers: |
828882 |
First Posted: | February 19, 2018 Key Record Dates |
Last Update Posted: | July 22, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Joint Diseases Musculoskeletal Diseases |