Automated Hovering for Joint Replacement Surgery

Not Applicable

Completed

• Conditions: Joint Disease
• Interventions: Behavioral: Remote monitoring plus goal setting and social support; Behavioral: Remote monitoring

• Registration Number: NCT03435549
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2018-02-07
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-19
• Primary Completion: 2019-04-12
• Study Completion: 2019-04-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2b: Remote monitoring plus goal setting and social support	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
Arm 2a: Remote monitoring	Remote monitoring	If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery

Primary Outcome Measures

Name	Time	Method
Discharged to home	Day of discharge through study completion at 6 weeks	% of patients discharged to home
Step increase	6 weeks post discharge	% of step increase as measured by activity tracker

Secondary Outcome Measures

Name	Time	Method
Days spent at home	6 weeks post discharge	Number of days spent at home after discharge
Timed Up and Go (TUG) score	6 weeks post discharge	% change in TUG score

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States