Automated Hovering for Joint Replacement Surgery
Primary Purpose
Joint Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote monitoring
Remote monitoring plus goal setting and social support
Sponsored by
About this trial
This is an interventional health services research trial for Joint Disease
Eligibility Criteria
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)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Arm 1: Control Arm (Usual care)
Arm 2a: Remote monitoring
Arm 2b: Remote monitoring plus goal setting and social support
Arm Description
If Patient is randomized to Arm 1, no contact will occur, patient will receive standard and routine clinical care
If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery
If Patient is randomized to Arm 2b, they will receive a remote monitoring plus social support and nudge messaging for 6 weeks post-surgery
Outcomes
Primary Outcome Measures
Discharged to home
% of patients discharged to home
Step increase
% of step increase as measured by activity tracker
Secondary Outcome Measures
Days spent at home
Number of days spent at home after discharge
Timed Up and Go (TUG) score
% change in TUG score
Full Information
NCT ID
NCT03435549
First Posted
February 9, 2018
Last Updated
July 18, 2019
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03435549
Brief Title
Automated Hovering for Joint Replacement Surgery
Official Title
Automated Hovering for Joint Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
April 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will evaluate the effectiveness of automated hovering to encourage patients to be discharged to home after hip or knee replacement surgery. Automated hovering includes monitoring of physical activity with an activity monitor, tracking of pain scores, daily feedback and motivational messages, social influence, and connection to clinicians as needed.
Detailed Description
The goal of this study is to test the approach of automated hovering to encourage patients to be discharged to home safely after lower extremity joint replacement surgery (LEJR). The investigators will target those patients undergoing hip or knee replacement surgery at a large urban hospital system at two different sites. The investigators aim is to increase the number of patients that are discharged to home, by providing patients with a physical activity pedometer, daily pain score tracking through bi-directional text messaging, milestone and nudge messaging for recovery, social influence, and connection to clinicians as needed for 6 weeks after surgery. Eligible participants are age 18-85, with a Risk Assessment and Prediction Tool (RAPT) score of 6-8 and are scheduled to undergo lower-extremity joint replacement surgery. Participants will be randomized 1:1 to usual care (Arm 1) and intervention (Arms 2a and 2b). After enrollment with the monitoring device, participants in the intervention group will be randomized 1:1 to Arm 2a (remote monitoring) or Arm 2b (remote monitoring + goal-setting and social support). Both intervention arms will receive the intervention for 6 weeks post-surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Control Arm (Usual care)
Arm Type
No Intervention
Arm Description
If Patient is randomized to Arm 1, no contact will occur, patient will receive standard and routine clinical care
Arm Title
Arm 2a: Remote monitoring
Arm Type
Experimental
Arm Description
If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery
Arm Title
Arm 2b: Remote monitoring plus goal setting and social support
Arm Type
Experimental
Arm Description
If Patient is randomized to Arm 2b, they will receive a remote monitoring plus social support and nudge messaging for 6 weeks post-surgery
Intervention Type
Behavioral
Intervention Name(s)
Remote monitoring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote monitoring plus goal setting and social support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Discharged to home
Description
% of patients discharged to home
Time Frame
Day of discharge through study completion at 6 weeks
Title
Step increase
Description
% of step increase as measured by activity tracker
Time Frame
6 weeks post discharge
Secondary Outcome Measure Information:
Title
Days spent at home
Description
Number of days spent at home after discharge
Time Frame
6 weeks post discharge
Title
Timed Up and Go (TUG) score
Description
% change in TUG score
Time Frame
6 weeks post discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33346847
Citation
Mehta SJ, Hume E, Troxel AB, Reitz C, Norton L, Lacko H, McDonald C, Freeman J, Marcus N, Volpp KG, Asch DA. Effect of Remote Monitoring on Discharge to Home, Return to Activity, and Rehospitalization After Hip and Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028328. doi: 10.1001/jamanetworkopen.2020.28328.
Results Reference
derived
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Automated Hovering for Joint Replacement Surgery
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