Automated Hovering for Joint Replacement Surgery

ID: NCT03435549
Status: Recruiting
Phase: N/A
Start Date: February 07, 2018
First Submitted: February 09, 2018
Last Updated: February 14, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania
Location: United States
Conditions: Joint Disease
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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.
Condition or disease Intervention/treatment Phase

Joint Disease

Behavioral: Remote monitoring
Other Names
Behavioral: Remote monitoring plus goal setting and social support
Other Names
N/A

Tracking Information

First Submitted DateFebruary 09, 2018
Last Update Posted DateFebruary 14, 2018
Actual Start DateFebruary 07, 2018
Anticipated Completion DateFebruary 01, 2019
Actual Primary Completion DateJuly 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleAutomated Hovering for Joint Replacement Surgery
Official TitleAutomated Hovering for Joint Replacement Surgery
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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
300
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Health Services Research
Conditions
Joint Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
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.

Other Names
Study Groups/Cohorts
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

Arm 2a: Remote monitoring
If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery

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

Study Arms
Experimental Arm 2a: Remote monitoring
If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery
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
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.

Arm Intervention/Treatment
Experimental Arm 2a: Remote monitoring
If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery
Behavioral : Remote monitoring
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
Behavioral : Remote monitoring plus goal setting and social support

Recruitment Information

Recruitment Status:Recruiting
Enrollment300
Completion DateFebruary 01, 2019
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)
GenderAll
Age18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03435549
Other Study ID Numbers
828882
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Not Available
Investigators
Principal Investigator
Shivan Mehta, MD
University of Pennsylvania